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FDA AI Medical Device Product Codes — Complete List
Every product code FDA has created for AI and ML-enabled medical devices — what each covers, when it was established, and how many devices have cleared under it.
When FDA clears a De Novo application, it creates a new product code and establishes special controls that govern all future 510(k) submissions in that category. For AI medical devices, these product codes are the regulatory foundation that determines your predicate options, your submission requirements, and your competitive landscape.
This is the only comprehensive list of FDA product codes established specifically for AI and ML-enabled devices, updated from CDRH public records.
Why Product Codes Matter for AI Device Strategy
Before searching for predicates, you need to know which product code your device falls under. The product code determines:
- Which De Novo decision governs your special controls
- Which cleared devices are eligible as predicates
- What performance testing FDA expects
- How long similar devices have taken to clear
For AI devices, most product codes were established through De Novo grants between 2018 and 2024. A small number predate the AI-specific era and have been applied to AI devices retroactively.
Core AI/ML Product Codes
QMF — AI-Based Software for Radiology
Established via DEN220043 (Eko Health, 2022). Covers AI software that analyzes cardiac auscultation data. Has since expanded to cover a broad range of radiology AI applications. One of the most-cited AI product codes with over 47 downstream 510(k) clearances. Average review time: 9.1 months.
OZO — Computer-Aided Detection for Radiology
One of the earlier AI product codes, covering computer-aided detection software for radiological imaging. Predates the De Novo AI era but has been applied extensively to modern AI-based CAD systems. Over 200 clearances, making it the highest-volume AI product code.
QNC — AI-Based Software for Mammography
Established via DEN180005 (iCAD, 2019). Covers AI software for mammographic image analysis, including density assessment and lesion detection. Approximately 15 downstream clearances. Average review time: 11.2 months.
QLL — AI Software for Musculoskeletal Analysis
Established via DEN210040 (Imagen Technologies, 2022). Covers AI-enabled analysis of musculoskeletal imaging, initially for wrist fracture detection. Has expanded to other orthopedic AI applications. Approximately 8 clearances to date.
QFP — AI Software for Cardiac Function
Established via DEN200080 (Caption Health, 2021). Covers AI software for echocardiographic image acquisition and quality assessment. Approximately 12 clearances. Average review time: 8.4 months.
PIE — AI-Based Pathology Software
Covers AI-enabled digital pathology analysis. Applied to whole-slide image analysis systems. Growing category with increasing clearance activity as digital pathology adoption accelerates.
PZB — AI Software for Ophthalmology
Covers AI-based analysis of retinal images. Among the earliest AI-specific product codes, driven by the IDx-DR De Novo in 2018. Established category with predictable review timelines.
OWJ — Autonomous Diagnostic AI (Ophthalmology)
Established via DEN160026 (Digital Diagnostics/IDx-DR, 2018) — the first autonomous AI diagnostic device cleared by FDA. Specifically covers AI systems that provide a diagnosis without clinician review. Very strict special controls. Few clearances outside the original De Novo.
OYP — AI Software for Neurology
Covers AI-based analysis of neurological data. Applied to EEG analysis, brain imaging AI, and neurological monitoring systems.
ODZ — AI-Based Dermatology Software
Established via DEN190040 (Skin Analytics, 2020). Covers AI software for skin lesion analysis and triage. Approximately 6 clearances to date.
QBS — AI Software for Sepsis Risk Prediction
Established via DEN220089 (Prenosis, 2024). Covers AI systems that stratify sepsis risk using laboratory values, vital signs, and patient demographics. Brand new category — expect significant 510(k) activity in 2025 and 2026.
MYN — AI Software for Oncology
Covers AI-based cancer detection and characterization software. Applied to imaging AI for tumor detection across multiple modalities.
PWF — AI Software for Cardiac Monitoring
Covers AI-based analysis of cardiac monitoring data including ECG and rhythm analysis. Applied to wearable cardiac AI and clinical monitoring systems.
MRZ — AI Software for Chest Imaging
Covers AI-based analysis of chest radiographs and CT. One of the busiest categories given the volume of chest imaging AI in development.
How to Use This List
Once you identify your product code, search CDRH's 510(k) database for all cleared devices under that code. Look for:
- Devices cleared in the last 24 months — most likely to be used as predicates
- Devices from well-known companies — regulators are familiar with these predicates
- Devices with the lowest review times — indicates a well-understood regulatory pathway
- Devices with PCCPs — shows FDA has accepted algorithm change protocols in this space
Product Codes on the Horizon
Several De Novo applications are pending for AI devices in cardiology, gastroenterology, and surgical AI. When granted, these will establish new product codes and open new predicate chains. AIFDA Intel tracks pending De Novo applications and alerts subscribers when new codes are created.
Product code data sourced from FDA CDRH public databases. Clearance counts and review times are approximate and based on AIFDA Intel analysis of public 510(k) records. Always verify at FDA.gov before making regulatory strategy decisions.