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 |
|---|---|---|---|---|---|
| K914962 | Fun Floss | Fun Floss Co. | JES | Class I | |
| K914744 | Sysmex Ne-1500, Modification | Toa Medical Electronics USA, Inc. | GKZ | Class II | |
| K914614 | Frames (Spectacles) Various Types | Match Optical Co. | HQZ | Class I | |
| K914576 | Keller Cardiac Monitor Medil Kms870 | Keller Medical Specialties Products, Inc. | DRT | Class II | |
| K914387 | Transcervical Intrauterine Kit | Telos Medical Corp. | HGS | Class II | |
| K914374 | Osteo Cerclage Wire | Osteo AG | JDQ | Class II | |
| K913793 | Simpex Inc. Oral and Rectal Thermometers | Simpex, Inc. | FLK | Class II | |
| K913625 | Electroscope Monitor, Em-1 | Electroscope, Inc. | GEI | Class II | |
| K913262 | Aesculap Surgical Accessories | Aesculap Inc | GEY | Class I | |
| K912781 | Electroshield | Electroscope, Inc. | GEI | Class II | |
| K912780 | Monopolar Laparoscopic Electrodes W/eletroshield | Electroscope, Inc. | GEI | Class II | |
| K912740 | Act-1 (Anterior Corneal Topographer) | Visionary Systems, Inc. | HLQ | Class I | |
| K912713 | S-Rom Zt Ha Proximal Femoral Sleeve | Joint Medical Products Corp. | MEH | Class II | |
| K911599 | Immunowell Lyme (P39 Recombinant) Test | General Biometrics, Inc. | LSR | Class II | |
| K911440 | Rapi-Ject(r) Syringe | David Bull Laboratories, USA, Inc. | FMF | Class II | |
| K910823 | Percudisc(tm) System | Percudisc, Inc. | GEX | Class II | |
| K915353 | Matrx Medical Maximizer 1000 and 2000 Vacuum Pump | Matrix Medica, Inc. | EIA | Class I | |
| K915120 | Tef/platinum Piston | River Medical, Inc. | ETB | Class II | |
| K915118 | Phaco Emulsification,irrigation/aspiration Tube | Ipax, Inc. | HQC | Class II | |
| K915112 | Magnetom 42 Sp,63 Sp,impact | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K915094 | Vortech's Image Archival and Retrieval System | Vortech Data, Inc. | LMB | Class I | |
| K914777 | Sigma Procedure No. 333-UV | Sigma Diagnostics, Inc. | DML | Class II | |
| K914482 | Stoma Measuring Device | Biosearch Medical Products, Inc. | FPD | Class II | |
| K914420 | Elisa Rubella Igm | Sclavo, Inc. | LFX | Class II | |
| K914324 | Cavity Varnish Product | Confi-Dental Products Co. | EMA | Class II | |
| K914229 | Phaco Tip | Tri-Star Ophthalmic | HQC | Class II | |
| K913770 | Advantage V.s. Ct/mr Rad Diagnostic Workstation | General Electric Co. | LNH | Class II | |
| K913521 | Xemex Temporary Pacing Catheter a Modified | Zeon Medical Corp. | LDF | Class II | |
| K913492 | Kirschner(r) Hybridfit Total Knee System | Kirschner Medical Corp. | JWH | Class II | |
| K913477 | Apex(tm) Prostatic Balloon Dilation Catheter | Peripheral Systems Group | KOE | Class II | |
| K913387 | Digitrapper Mark III | Synectics-Dantec | FFT | Class I | |
| K913175 | Miracle Mix Caps Glass Ionomer Cement Incapsules | G-C Intl. Corp. | EJJ | Class II | |
| K913129 | Angiolaz Angioscope Catheter | Angiolaz, Inc. | LYK | Class II | |
| K912735 | Genesis Unicompartmental Knee System | Smith & Nephew Richards, Inc. | HSX | Class II | |
| K911702 | Olympus Retractable Valvulotome | Olympus Corp. | MGZ | Class II | |
| K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | LOS | ||
| K914316 | Cepti-Seal Dressing Change Kit for Cent Ven Cath | Medi-Flex Hospital Products, Inc. | LYY | Class I | |
| K912985 | Lima 28Mm Ceramic Head, Modification | Turnkey Intergration USA, Inc. | LZO | Class II | |
| K912747 | Lulmitex Neonatal Transilluminator | Lumitex Medical Devices, Inc. | HJN | Class I | |
| K912384 | Disposable Supplies Kit for Pea Procedure | Nidek, Inc. | HQE | Class II | |
| K915121 | Tef/wire Piston | River Medical, Inc. | ETB | Class II | |
| K914990 | Advance(r) Pregnancy Test | Ortho Pharmaceutical Corp. | LCX | Class II | |
| K914433 | Medtronic Mdls 3487/3487A/3587/3587a Scs Leads | Medtronic, Inc. | GZB | Class II | |
| K914396 | Surgi Light Non-Contact Fibers | Lifestream Int'L, Inc. | GEX | Class II | |
| K914284 | Patient Examination Gloves | K-International Exports Pvt., Ltd. | LYY | Class I | |
| K913108 | Teflon Coated Electrodes/electrodes Handles | Olsen Electrosurgical, Inc. | GEI | Class II | |
| K912994 | Compalux Stroboscopic Light Polymerization Device | Wilde-USA, Inc. | EBZ | Class II | |
| K912581 | Zeiss Confocal Laser Scanning Ophthalmoscope(clso) | Carl Zeiss, Inc. | HLI | Class II | |
| K912409 | Model Hd-207 Bidirectional Velocity Meter | Koven and Assoc., Inc. | JOP | Class II | |
| K911730 | Surgical Obturator with Seal | Applied Vascular Devices, Inc. | GCJ | Class II |