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 |
|---|---|---|---|---|---|
| K910084 | Surgical Drape | Biocor Medical, Inc. | KKX | Class II | |
| K905405 | Chemtrak Accumeter Cholesterol Test | Chemtrak, Inc. | CHH | Class I | |
| K905282 | Endoscopic Accessory to the Light Source | Frantz Medical Development, Ltd. | GCT | Class II | |
| K905088 | Hot Biopsy Forceps | Esco Precision, Inc. | KGE | Class II | |
| K904904 | Medicopaste Bandage with Calamine/modification | Graham-Field, Inc. | KGX | Class I | |
| K904646 | Bci-100 Fecal Incontinence System | Biocare Intl. | FAP | Class II | |
| K902550 | EEG-5400 Series | Nihon Kohden America Inc | GWQ | Class II | |
| K896450 | Neuro N 50 Lesion Generator | Leibinger & Fischer, Ltd. | GXD | Class II | |
| K910368 | Mega Laceration Kit | Megadyne Medical Products, Inc | LRO | Class II | |
| K910314 | C Abra Model Linear, Low Dr. Custom Canal Hear Aid | Ototech, Ltd. | ESD | Class I | |
| K910313 | Abra Ipc Model Input Compres Agccust Ite Hear Aid | Ototech, Ltd. | ESD | Class I | |
| K910312 | C Abra Model Linear, Low Drain Cust Canal Hear Aid | Ototech, Ltd. | ESD | Class I | |
| K910311 | Abra Model Line Low Drain Cust in-the-Ear Hear Aid | Ototech, Ltd. | ESD | Class I | |
| K905796 | Dose Calibrator | Capintec Instruments, Inc. | KPT | Class II | |
| K905784 | Custom Ite Hearing Aid | Hearing Aid Co. | ESD | Class I | |
| K905715 | Acs Angioscopic Catheter | Advanced Cardiovascular Systems, Inc. | DQO | Class II | |
| K905654 | Electrosurgical Unit with Accessories | Aspen Labs | GEI | Class II | |
| K905067 | Pti Anastomark Flexible Coronary Bypass Graft | Pioneering Technologies, Inc. | DSY | Class II | |
| K904988 | Palco Labs Model 400 Oxygen/pulse Monitor | Palco Laboratories, Inc. | DQA | Class II | |
| K904267 | Zoex Antishock Trousers | Zoex Corp. | JOW | Class II | |
| K904159 | Defibrillator Analyzer Model Qed-5 | Bio-Tek Instruments, Inc. | DRL | Class II | |
| K910904 | Intego | Racal Health & Safety, Inc. | HQY | Class I | |
| K910803 | Enamel Etching Gel | Gresco Products, Inc. | DYH | Class II | |
| K910669 | 5 Mhz Adult/pedi Transesophageal Echo(tee) Transdu | Siemens Ultrasound, Inc. | ITX | Class II | |
| K910632 | Accu-Mix Amalgamator | Wykle Research, Inc. | EFD | Class I | |
| K910529 | 7.5 Mhz Pediatric Transesophageal Echo (Tee) Trans | Siemens Ultrasound, Inc. | ITX | Class II | |
| K910375 | Helical Scan | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K910260 | Corometrics Mdl 330 Fetal/maternal Telemetry Syst | GE Medical Systems Information Technologies, Inc. | HGM | Class II | |
| K910134 | Optical Frame (Helen,arnold,vana,bruce,matt) | Kentucky Optical Co. | HQZ | Class I | |
| K910068 | Spectramat | Ivoclar North America, Inc. | EBZ | Class II | |
| K910065 | Gdc-3200 Dental Solder | Deringer-Ney, Inc. | EJT | Class II | |
| K905728 | Sonos 500 and Sonos 1000 Ultrasound Imaging System | Hewlett-Packard Co. | DPT | Class II | |
| K905723 | Ionoseal | Micro-Vac, Inc. | EJK | Class II | |
| K905703 | Krupin Eye Valve with Disk | Hood Laboratories | KYF | Class II | |
| K905664 | Vial Access Cannula | Baxter Healthcare Corporation | FMI | Class II | |
| K905371 | Ite Hearing Aid | Audicare Hearing Center | ESD | Class I | |
| K905157 | Floscope Vascular Lab. | Advance Medical Device, Inc. | JOP | Class II | |
| K905131 | Durafill Color Vs | Kulzer GmbH | EBF | Class II | |
| K905122 | Sentry Scale | Apollo Enterprise, Ltd. Co. | FRW | Class I | |
| K905062 | Injector, Insulin | Sound 2000 Medical Systems, Inc. | KZE | Class II | |
| K905045 | Nerve Locator/stimulator | Apyx Medical Corporation | ETN | Class II | |
| K905032 | Mousse, Polyvinyl Siloxane Impression Material | Parkell, Inc. | ELW | Class II | |
| K905021 | Acetate Concentrates for Hemodialysis | Medical Components, Inc. | KPO | Class II | |
| K904937 | Playtex Ultimates Unscented and Scented Tampons | Playtex Family Products, Inc. | HEB | Class II | |
| K904859 | Motor Driven Extirpation Instruments | Aesculap Inc | HRX | Class II | |
| K904756 | Matrics | Kerr Corporation (Danbury) | ESD | Class I | |
| K904703 | Bc-1201 Cast Abutment | Minimatic Implant Technology | DZE | Class II | |
| K904669 | Balloon Catheters | Olympus Corp. | FGE | Class II | |
| K904620 | Steraid Disposable Syringe | Disposable Medi-Aids, Ltd. | FMF | Class II | |
| K903577 | Dynatron 200 Microcurrent | Dynatronics Corp. | GZJ | Class II |