510(k) Regulatory Strategy Consulting

Serving clients across SaMD · wearables · diagnostics · surgical instruments · Class II devices · AI/ML-enabled devices

The iAIR Institute brings together regulatory science, clinical informatics, and AI-powered workflow intelligence to guide your 510(k) submission — from predicate strategy to clearance letter.

Why iAIR Institute

Most consultants bring regulatory checklists. We bring a complete intelligence layer — combining FDA regulatory science, clinical evidence methodology, and purpose-built AI tools to reduce submission risk and accelerate your timeline.

iAIR Labs Intelligence Platform

Our proprietary tools, developed at iairlabs.com, perform automated predicate screening, RTA gap analysis, and 510(k) section drafting — giving your submission a structural advantage before FDA’s first review.

AIRM Health Group Clinical Depth

Through our partnership with airmidhealthgroup.com, we access clinical and health economics expertise that strengthens your clinical performance data, indications for use, and risk-benefit arguments under ISO 14971.

Predicate Strategy First

Selecting the right predicate is the most consequential early decision. We run a structured predicate suitability analysis — evaluating intended use alignment, technological character delta, and NSE risk — before any documentation begins.

eSTAR-Ready Submissions

We build submissions natively in FDA’s eSTAR interactive PDF format. Our structured templates eliminate common formatting rejections and are pre-mapped to CDRH’s RTA checklist requirements.

Testing Strategy Design

We define your full testing protocol: bench performance, biocompatibility per ISO 10993, electrical safety, EMC, software validation under IEC 62304, and clinical data requirements — before you spend on testing.

FDA Response Management

If FDA issues an Additional Information (AI) request, we manage the complete response — identifying the root cause, drafting supplemental data, and re-engaging the reviewer to keep your review on track.

Our Process: From Product Concept to K-Number

A structured, milestone-driven engagement designed to eliminate surprises and maximise your first-submission success rate.

Step 1 — Device Classification & Predicate Analysis

FDA database review, product code identification, predicate suitability scoring.

Step 2 — Regulatory Strategy & Testing Plan

Testing matrix, applicable standards mapping, special controls compliance.

Step 3 — Documentation Build

eSTAR-native drafting: indications for use, SE comparison, labelling, performance data.

Step 4 — Internal RTA Review & Submit

Pre-submission RTA checklist audit, CDRH portal submission, fee coordination.

Step 5 — Review Management & Clearance

Reviewer liaison, AI response drafting, clearance letter receipt.

What We Deliver

Every engagement produces a structured, FDA-ready submission package. Here is exactly what you receive.

Regulatory Strategy

• Device classification memo
• Predicate screening report
• Substantial equivalence argument
• Applicable standards list
• Testing protocol matrix

Core Submission Sections

• Cover letter & IFU statement
• 510(k) Summary or Statement
• Device description narrative
• SE comparison table
• Labelling package review

Technical Documentation

• Bench testing summary
• Biocompatibility (ISO 10993) matrix
• Software documentation (IEC 62304)
• EMC & electrical safety summary
• Risk analysis (ISO 14971) review

Submission Infrastructure

• eSTAR-formatted interactive PDF
• RTA pre-check report
• CDRH portal submission package
• User fee coordination
• Establishment registration guidance

AI/ML-Enabled Devices

• SaMD classification framework
• PCCP (Predetermined Change Control)
• Algorithm transparency documentation
• AI/ML Action Plan alignment
• Clinical validation design

Post-Submission Support

• Day 15 acceptance confirmation
• Reviewer communication support
• AI request response drafting
• NSE/De Novo pivot strategy
• Post-clearance compliance guidance

Who We Serve

Whether you are a solo inventor with a prototype or a funded startup approaching your first submission, we meet you where you are.

Early-Stage Founders

Pre-submission strategy and device classification review before you commit to a testing budget — so you build toward clearance from day one.

Established Device Companies

510(k) for modified, expanded-indication, or next-generation devices. We integrate with your existing QMS and regulatory affairs team.

AI/SaMD Developers

Navigating AI/ML-enabled device regulations, SaMD risk classification, PCCP frameworks, and FDA’s evolving guidance for software as a medical device.

International Entrants

Foreign manufacturers seeking U.S. market entry via 510(k). We handle U.S. Agent designation, facility registration, and FDA liaison strategy.

Combination Product Teams

Drug-device and biologic-device combinations navigating primary mode of action determinations, lead centre assignment, and dual submission strategies.

Investors & Acquirers

Regulatory due diligence reviews — we assess submission quality, clearance risk, and post-market compliance posture for M&A and investment decisions.

Service Tiers

We scope every engagement to your device, your timeline, and your team’s existing capabilities.

Strategy Sprint

For teams mapping their regulatory path.

• Device classification analysis
• Predicate suitability report
• Testing matrix & gap analysis
• Regulatory strategy memorandum
• 1 strategy session (90 min)
• Pre-submission (Q-Sub) guidance

Full Submission — Most Requested

End-to-end 510(k) management.

• Everything in Strategy Sprint
• Complete eSTAR documentation
• Technical file build-out
• Internal RTA pre-check
• CDRH portal submission
• Post-submission review management
• AI response support (up to 2 cycles)

Enterprise Partner

Ongoing regulatory infrastructure.

• Dedicated regulatory lead
• Multiple concurrent submissions
• QMS integration support
• Post-market surveillance support
• MDR reporting & MAUDE review
• International pathway advisory
• Priority access to iAIR tools

FDA 510(k) user fees for FY2025: approximately $22,500 standard / $5,600 small business. We provide fee estimation and eligibility guidance as part of every engagement.

Frequently Asked Questions

How do I know if my device needs a 510(k)?

Not every medical device requires a 510(k) submission. The pathway depends on how your device is classified by the FDA — Class I devices are often exempt, most Class II devices require a 510(k), and Class III devices typically require the more rigorous Premarket Approval (PMA) process. For environmental health technologies like air purification systems, UV disinfection devices, and infection control products, classification can be less straightforward than it appears. One of the first things we do in any engagement is confirm your device’s correct classification and regulatory pathway — before you commit time or budget to the wrong route.

How long does the 510(k) process take?

Once submitted, FDA has a 90-day substantive review target under MDUFA V — but that clock only starts after your submission passes the initial 15-day acceptance review. In practice, total timeline from project start to clearance letter typically ranges from 9 to 18 months depending on device complexity, testing requirements, and whether FDA issues an Additional Information request. The biggest variable is how well-prepared the submission is before it reaches FDA. A rigorous predicate strategy and a complete, RTA-proof submission package are the most reliable ways to keep that timeline at the shorter end.

What makes iAIR Institute different from other regulatory consultants?

Most regulatory consultants bring documentation expertise. We bring that plus two things most firms cannot offer. First, iAIR Labs’ AI-powered tools for predicate screening, gap analysis, and submission drafting — which means our submissions are structurally stronger before FDA ever sees them. Second, our partnership with Airmid Healthgroup gives us in-house access to specialist aerobiology and environmental testing capabilities — bioaerosol chamber testing, UV disinfection validation, filtration performance studies — that are directly relevant to the device categories we focus on. For innovators in air purification, infection control, and environmental health, that combination is genuinely unique.

What happens if FDA issues an Additional Information request or an NSE decision?

An Additional Information (AI) request — where FDA asks for clarification or supplemental data — is common and manageable if handled correctly. We manage the complete response process: identifying the root cause of the request, drafting the response, and re-engaging the reviewer. An NSE (Not Substantially Equivalent) decision is more serious, but it is not necessarily the end of the road. Depending on the grounds for the NSE, options include the De Novo classification pathway for novel low-to-moderate risk devices, or a revised 510(k) with a stronger predicate argument. We assess all options and recommend the most efficient forward path.

Can you help if we have already started our submission or had a previous rejection?

Yes — and this is something we do regularly. Whether you have a partially completed submission that needs strengthening, a previous RTA that needs addressing, or an NSE decision you want to understand and respond to, we can step in at any stage. We begin with an honest assessment of where things stand, what the gaps are, and what it realistically takes to get to clearance. There is no obligation beyond that first conversation.

Ready to Move Your Device Toward Market?

Every successful 510(k) starts with one conversation. Tell us about your device — we will give you an honest assessment of your path, timeline, and what it takes to get there.

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