510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K905390 | Kudo (Powered Rotation Bed) | KCI USA, Inc. | IKZ | Class II | |
| K905277 | Micro-Aire 4220-000 Oscillating Saw | Micro Surgical Instruments Corp. | HSZ | Class I | |
| K905250 | Lobow | Perinatal Systems | LIT | Class II | |
| K905104 | Model 3100-64: Quadrature Spine Coil | Medical Advances, Inc. | LNH | Class II | |
| K904903 | Paraderm(tm) Surgeon's Glove Accessory | Lovell-Schenck, Inc. | LYU | Class I | |
| K904874 | Adjustable PEEP Valve | Vital Signs, Inc. | BYE | Class II | |
| K904794 | In-Line Ats Blood Recovery Bag | Atrium Medical Corporation | CAC | Class II | |
| K904741 | Laserdish Poly Unipolar Ventri Lead W/trail Tines | Telectronics Pacing Systems, Inc. | DTB | Class III | |
| K904739 | Dynapulse 200M | Pulse Metric, Inc. | DXN | Class II | |
| K904109 | Bio-Impedance Analyzer | Xitron Technologies, Inc. | DSB | Class II | |
| K903900 | Smu 611 Vers. 2.0 Including Pressni,dilu,sat-Mod. | Ppg Hellige B.V. | DSK | Class II | |
| K903618 | Robertazzi Nasopharyngeal Airway | Eastmed Enterprises, Inc. | BTQ | Class I | |
| K903134 | Omron Auto Oscillometric Dig Bp Mont/hem-704C 705C | Omron Marshall Products, Inc. | DXN | Class II | |
| K902506 | 7200Ae Microprocessor Ventilator W/enhanced Hard. | Medtronic, Inc. | CBK | Class II | |
| K895964 | Dcl Syphilis-M Catalog No. 600-80 | Diagnostic Chemicals, Ltd. (USA) | LIP | Class II | |
| K904629 | Centauri Yag Laser Syst, Urology | Pfizer Laser Systems | GEX | Class II | |
| K904628 | Centauri Yag Laser Syst, Gastroenterology | Pfizer Laser Systems | GEX | Class II | |
| K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | GEX | Class II | |
| K904604 | Redi-Release Absorbent Dressing | Fountain Pharmaceuticals, Inc. | KOZ | Class I | |
| K905662 | Systemate Ggt (Epos Application) #65414 | Em Diagnostic Systems, Inc. | JQB | Class I | |
| K905406 | Osteonics Hip Revision Wedges | Osteonics Corp. | JDI | Class II | |
| K905358 | Cancellous Screw | O'Tec Corp. | HWC | Class II | |
| K905357 | Cortical Bone Screw (European Style) | O'Tec Corp. | HWC | Class II | |
| K905355 | Broad Self-Compressing Plate | O'Tec Corp. | HRS | Class II | |
| K905347 | Hagie Pin | O'Tec Corp. | JDW | Class II | |
| K905333 | u.s. Type Cruciate Slot Bone Screw | O'Tec Corp. | HWC | Class II | |
| K905158 | Osteonics(r) 6011 Hip Stem Series | Osteonics Corp. | JDI | Class II | |
| K905144 | Eclipse Ica Glucose | Biotope, Inc. | CFR | Class II | |
| K905112 | Snap-Pak (Tm) | Mitek Surgical Products, Inc. | JDR | Class II | |
| K904933 | Various Afterloading Applicators | Best Assoc. Corp. | IWJ | Class I | |
| K904912 | Transducer Protector | Filtertek, Inc. | FIB | Class II | |
| K904808 | Electrosurgical Pencil | Megadyne Medical Products, Inc | GEI | Class II | |
| K904207 | Biopro Trinity Acetabular Cup | Biopro, Inc. | JDI | Class II | |
| K904174 | Starcam 4000 | General Electric Co. | IYX | Class I | |
| K904127 | A2j Telemeter | A2j, Inc. | IWE | Class I | |
| K903938 | C Fit Cup | Mizuho Orthopedic Systems Inc | JDI | Class II | |
| K903674 | Model 295 Electronic Respirometer | National Medical Sales, Inc. | BZK | Class II | |
| K902167 | Contain(tm) Laser Plume Filter | Arbor Technologies, Inc. | JDY | Class I | |
| K901927 | Ha-Ti (Hand-Titanium Screw) Implant | Mathys Corp. of North America | DZE | Class II | |
| K905566 | Kodak Ektascan Multi-Format Imager Various Models | Eastman Kodak Company | LMC | Class II | |
| K905486 | Immunowell Tpo (Microsome) Test | General Biometrics, Inc. | JNL | Class II | |
| K905149 | Titan Gel | Helena Laboratories, Corp. | DAH | Class II | |
| K904941 | Maestro Series 100/200 Cardiac Single Chamber Pace | Cardiac Control Systems, Inc. | DXY | Class III | |
| K904884 | Acs Urethan Coronary Guiding Catheter | Advanced Cardiovascular Systems, Inc. | DQY | Class II | |
| K904602 | Medtronic Model 5301B Test Cable | Medtronic, Inc. | DXY | Class III | |
| K904275 | Morse Balloon Inflation Device | North American Instrument Corp. | MAV | Class II | |
| K904114 | Anatech X-Ray Generator | Continental X-Ray Corp. | IZO | Class I | |
| K904083 | Rubeola Igm Elisa Test | Gull Laboratories, Inc. | LJB | Class I | |
| K903939 | Panda Helium Gas Analyzer | Medical Associated Services, Inc. | BSE | Class II | |
| K903671 | Athans EKG Standardizer | Advanced Medical Concepts, Inc. | DPS | Class II |