FDA device product codes
FDA classifies devices with three-letter product codes. Each maps to a 21 CFR section, a class (I/II/III) and a marketing pathway. Source: openFDA (CC0).
Unknown902 product codesGastroenterology, Urology564 product codesGeneral, Plastic Surgery554 product codesClinical Chemistry527 product codesMicrobiology511 product codesHematology387 product codesCardiovascular348 product codesDental328 product codesGeneral Hospital322 product codesOphthalmic310 product codesImmunology289 product codesOrthopedic278 product codesClinical Toxicology268 product codesObstetrics/Gynecology256 product codesEar, Nose, Throat235 product codesAnesthesiology229 product codesNeurology229 product codesPhysical Medicine220 product codesRadiology199 product codesPathology128 product codesMedical Genetics7 product codes
510(k) without a matching product code (17)
- DEN230011 — OcuCool (code QZQ)
- DEN250046 — Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 U (code SIW)
- DEN250049 — Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring S (code SJD)
- K240226 — Pixie Skin Tag (code ORE)
- K242272 — CORIOGRAPH Pre-Op Planning and Modeling Services
- K243461 — Calibrate Interbody Systems
- K243598 — Welch Allyn Connex® 360 (Multiple)
- K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (code PRD)
- K251576 — Total Flow Medical Femoral Arterial (TFA) cannula (code SFF)
- K252336 — Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Ass
- K252923 — IASIS i2 Relaxation Neurofeedback System
- K253306 — BioTracker 2.0
- K253404 — CLEAR Aspiration System
- K253653 — Xpert Hemorrhagic Fever
- K254211 — pVasc Net Mechanical Thrombectomy Device
- K260885 — VERAFEYE Imaging and Guidance System (VF-VIS-002)
- K261775 — Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)