FDA 510(k) · Airmid Healthgroup
510(k) Testing & Consulting for Medical Device Manufacturers
Airmid Healthgroup combines FDA 510(k) consulting with ISO/IEC 17025-accredited, GLP-capable laboratory testing. From predicate strategy and test planning to the data in your submission and your response to FDA, one team takes your device from concept to clearance letter.
Test + Consult
Lab data and regulatory strategy under one roof
ISO 17025 · GLP
Accredited, FDA-ready test reports
eSTAR-Ready
Submissions mapped to FDA’s RTA checklist
510(k) support for air purification & infection-control devices · antimicrobial & antiviral medical textiles · diagnostics · wearables · SaMD & AI/ML-enabled devices · Class II devices
Overview
What is 510(k) testing and consulting?
A 510(k) premarket notification asks FDA to clear your device on the basis that it is substantially equivalent to a legally marketed predicate. That argument stands or falls on two things: a sound regulatory strategy, and test data that proves equivalence for the characteristics FDA cares about.
Most manufacturers buy those two things from different suppliers who never speak to each other. At Airmid Healthgroup, 510(k) consulting and testing happen in one place: the regulatory team that chooses your predicate and writes your submission works alongside the scientists who generate your performance data, so the tests you pay for are the tests your 510(k) actually needs.
Predicate strategy first
We assess intended-use alignment, differences in technological characteristics and NSE risk before any documentation or testing begins.
Testing strategy design
We map FDA-recognised consensus standards to your device and build the testing matrix: performance and efficacy, biocompatibility (ISO 10993), electrical safety and EMC, and software (IEC 62304).
eSTAR-ready submissions
We build submissions natively in FDA’s eSTAR format, pre-checked against the Refuse to Accept (RTA) criteria to avoid administrative rejection.
FDA response management
If FDA issues an Additional Information (AI) request, we find the root cause, generate any supplemental data in our own labs and draft the response.
510(k) Testing
Accredited 510(k) testing from our own laboratories
Our ISO/IEC 17025-accredited, GLP-capable laboratories generate the performance and efficacy data that 510(k) submissions for air-treatment, infection-control and antimicrobial products depend on. Reports are written to be submitted to US FDA and US EPA.
Bioaerosol & airborne pathogen efficacy
Chamber testing of air purifiers, air-handling and UV devices against airborne bacteria, viruses and fungi, including ISO 15714.
Virology & antiviral testing
Antiviral efficacy data for medical textiles, surfaces and device materials, including ISO 18184.
Microbiology & antimicrobial claims
Antimicrobial surface and material testing to substantiate infection-control performance claims.
GLP studies
Non-clinical laboratory studies conducted under Good Laboratory Practice where FDA expects GLP-compliant data.
Where your device needs testing outside our laboratory scope, such as biocompatibility or IEC 60601 electrical safety, we specify the protocol, help you choose an appropriately accredited laboratory and integrate the results into your submission. View all Airmid testing services →
Our Engagement Process
From product concept to K-number
A milestone-driven 510(k) engagement designed to remove surprises and maximise your first-submission success.
1
Classification & predicate analysis
FDA database review, product code identification, predicate suitability scoring
2
Regulatory strategy & testing plan
Testing matrix, recognised standards mapping, special controls, Q-Sub where useful
3
510(k) testing
Performance and efficacy testing in our accredited labs; partner testing coordinated
4
Documentation & RTA review
eSTAR drafting, SE comparison, labelling, internal RTA audit, CDRH Portal submission
5
Review management & clearance
Reviewer liaison, AI response drafting, clearance letter
What We Deliver
A complete 510(k) submission package
Every engagement produces a structured, FDA-ready package, not a document dump. Here is what you receive.
Regulatory strategy
- Device classification memo
- Predicate screening report
- Substantial equivalence argument
- Applicable standards list
- Testing protocol matrix
Test data & reports
- Accredited performance and efficacy test reports
- GLP study reports where required
- Bench testing summary
- Biocompatibility (ISO 10993) matrix
- EMC and electrical safety summary
Core submission sections
- Cover letter and Indications for Use
- 510(k) Summary or Statement
- Device description
- SE comparison table
- Labelling review
Submission infrastructure
- eSTAR-formatted submission
- RTA pre-check report
- CDRH Portal submission package
- User fee and small business guidance
- Establishment registration guidance
AI/ML-enabled devices
- SaMD classification
- Predetermined Change Control Plan (PCCP)
- Software documentation (IEC 62304)
- Algorithm transparency documentation
- Clinical validation design
Post-submission support
- Acceptance review tracking
- Reviewer communication support
- AI request response drafting
- NSE / De Novo pivot strategy
- Post-clearance compliance guidance
Who We Serve
510(k) support for innovators at every stage
Whether you have a prototype or a funded programme approaching submission, we meet you where you are.
Air purification & infection-control devices
Our specialism. Bioaerosol efficacy data and predicate strategy for air cleaners, UV systems and infection-control technologies. Infection-control testing →
Early-stage founders
Classification and pre-submission strategy before you commit a testing budget, so you build toward clearance from day one.
Established device companies
510(k)s for modified, expanded-indication or next-generation devices, integrated with your QMS and regulatory affairs team.
AI/SaMD developers
SaMD risk classification, PCCPs and FDA’s evolving guidance for AI-enabled device software.
International manufacturers
US market entry via 510(k), including US Agent designation, establishment registration and FDA liaison.
Investors & acquirers
Regulatory due diligence on submission quality, clearance risk and post-market compliance.
Expert Insight
510(k) Cleared: The Regulatory Decisions That Actually Move the Needle
FDA guidance tells you what to submit. It does not tell you where most submissions fail. Dr. Matthew Hardwick’s practitioner guide covers predicate strategy, common RTA failure modes, eSTAR navigation and what substantial equivalence really requires.
Service Tiers
510(k) engagement options sized for your stage
We scope every engagement to your device, timeline and in-house capability. These tiers are a starting framework.
Strategy Sprint
For teams mapping their regulatory path · scoped engagement
- Device classification analysis
- Predicate suitability report
- Testing matrix and gap analysis
- Regulatory strategy memorandum
- 90-minute strategy session
- Pre-submission (Q-Sub) guidance
Most requested
Full Submission
End-to-end 510(k) testing and submission · per submission
- Everything in Strategy Sprint
- 510(k) testing in our accredited labs
- Complete eSTAR documentation
- Internal RTA pre-check
- CDRH Portal submission
- Review management to clearance
- AI response support (up to 2 cycles)
Enterprise Partner
Ongoing regulatory and testing capacity · monthly retainer
- Dedicated regulatory lead
- Multiple concurrent submissions
- Priority laboratory scheduling
- QMS integration support
- Post-market surveillance and MDR reporting
- International pathway advisory
FDA 510(k) user fees for FY2027 (1 Oct 2026 – 30 Sep 2027): $28,653 standard / $7,163 qualifying small business, plus the annual establishment registration fee. We provide fee estimates and small business eligibility guidance in every engagement.
Common Questions
510(k) testing and consulting FAQs
What is a 510(k) submission?
A 510(k), or premarket notification, is a submission to the US FDA showing that a new medical device is substantially equivalent to a legally marketed predicate device. Most Class II devices, and some Class I devices, reach the US market this way. Novel low-to-moderate risk devices with no suitable predicate may use the separate De Novo pathway instead.
What testing does a 510(k) require?
It depends on the device, its intended use and its predicate. Typical 510(k) testing includes bench performance or efficacy testing, biocompatibility (ISO 10993) for patient-contacting devices, electrical safety and EMC (IEC 60601) for powered devices, software validation (IEC 62304), and sterility or shelf-life testing where relevant. FDA-recognised consensus standards are the most direct route. We build your testing matrix before you spend on testing.
Can Airmid Healthgroup carry out 510(k) testing?
Yes. Our ISO/IEC 17025-accredited, GLP-capable laboratories perform bioaerosol, airborne pathogen, antiviral, antimicrobial and allergen testing that supports 510(k) submissions, particularly for air-treatment, infection-control and antimicrobial products. For tests outside our scope, we specify the protocol and integrate partner laboratory results into your submission.
How long does the 510(k) process take?
FDA’s review goal is 90 FDA days from acceptance. Total time to clearance, including predicate research, testing, documentation and any Additional Information request cycles, is typically several months longer. We give you a realistic timeline at the start of every engagement.
How much are FDA 510(k) user fees?
For FDA fiscal year 2027 (1 October 2026 to 30 September 2027), the standard 510(k) user fee is $28,653 and the qualifying small business fee is $7,163. Small business status must be granted by FDA before you submit. Most establishments also pay an annual registration fee, which is not reduced for small businesses.
What happens if FDA questions our predicate or requests more information?
If FDA issues an Additional Information request, we identify the root cause, generate any supplemental data and draft the response. If a device is found not substantially equivalent (NSE), we help you evaluate an alternative predicate or the De Novo pathway.
What is eSTAR, and why does it matter?
eSTAR is FDA’s electronic submission template, required for most 510(k)s. We build documentation natively in eSTAR, pre-checked against the Refuse to Accept criteria, to reduce the risk of administrative rejection.
Do you support AI/ML-enabled and SaMD devices?
Yes. We support Software as a Medical Device and AI-enabled device submissions, including SaMD risk classification, Predetermined Change Control Plans and algorithm transparency documentation.
Can manufacturers outside the US use your 510(k) consulting services?
Yes. We regularly support European and international manufacturers entering the US market via 510(k), including US Agent designation, establishment registration and FDA liaison. Our policy and regulatory work in Washington DC is delivered with our group partner, the iAIR Institute. MedTech policy & regulatory affairs →
Get Started
Talk to our 510(k) team
Tell us about your device. We will give you an honest assessment of your 510(k) pathway, the testing you need, and the timeline to clearance.
Airmid Healthgroup works as part of a connected group with the iAIR Institute and iAIR Labs, combining laboratory testing, regulatory consulting and policy expertise.
