Serving clients across SaMD · wearables · diagnostics · surgical instruments · Class II devices · AI/ML-enabled devices
Why iAIR Institute
Regulatory expertise meets the precision of modern AI
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.
Airmid 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 precise root cause, drafting supplemental data, and re-engaging the reviewer to keep your review on track.
Our Engagement Process
From product concept to K-number
A structured, milestone-driven engagement designed to eliminate surprises and maximize your first-submission success rate.
Device Classification & Predicate Analysis
FDA database review, product code identification, predicate suitability scoring
Regulatory Strategy & Testing Plan
Testing matrix, applicable standards mapping, special controls compliance
Documentation Build
eSTAR-native drafting: indications for use, SE comparison, labeling, performance data
Internal RTA Review & Submit
Pre-submission RTA checklist audit, CDRH portal submission, fee coordination
Review Management & Clearance
Reviewer liaison, AI response drafting, clearance letter receipt
What We Deliver
A complete 510(k) submission package
Every engagement produces a structured, FDA-ready submission package — not just a document dump. Here’s 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
- → Labeling 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
Built for innovators at every stage
Whether you’re 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 center 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.
From the iAIR Institute
The Expert’s Guide to 510(k): What the Process Doesn’t Tell You
The FDA’s official guidance documents tell you what to submit. What they don’t tell you is where most submissions fail — and how to structure a predicate argument that survives substantive review.
Our regulatory scientists have distilled the critical decision points, common RTA rejection triggers, and the strategic choices that determine whether you receive a clearance letter or an NSE decision.
Expert Insight · iAIR Institute
510(k) Cleared: The Regulatory Decisions That Actually Move the Needle
A practitioner’s deep-dive into predicate strategy, RTA failure modes, eSTAR navigation, and the real meaning of substantial equivalence.
Read the guide →
Service Tiers
Engagement options sized for your stage
We scope every engagement to your device, your timeline, and your team’s existing capabilities. These tiers serve as a starting framework.
FDA 510(k) user fees for FY2025: ~$22,500 standard / ~$5,600 small business. We provide fee estimation and eligibility guidance as part of every engagement.
Get Started
Ready to move your device toward market?
Every successful 510(k) starts with one conversation. Tell us about your device — we’ll give you an honest assessment of your path, timeline, and what it takes to get there.
Also available via AIRM Health Group · info@iairlabs.com
