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 |
|---|---|---|---|---|---|
| K971906 | Jejenostomy Feeding Tube | Boston Scientific Corporation | FPD | Class II | |
| K971894 | Kodak Digital Science - Dental Scanning System | Eastman Kodak Company | LMA | Class II | |
| K971884 | Asset Apollo | Philips North America LLC | LNH | Class II | |
| K971677 | Accu-Surg Bi-Polar Electrodes, L-Hook, Needle, Ball, Bipolar Cord | Transamerican Technologies Intl. | GEI | Class II | |
| K971638 | Clarithromycin Antimicrobial Susceptibility Test Disc | Oxoid, Ltd. | JTN | Class II | |
| K971585 | Immunocard Stat! Rotavirus | Meridian Diagnostics, Inc. | LIQ | Class I | |
| K971503 | Mycoplasma Igm Elisa Test System | Zeus Scientific LLC | LJZ | Class I | |
| K970298 | Dm-400 Holter ECG Cassette Recorder | Diagnostic Monitoring | DSH | Class II | |
| K965032 | The Perioseal Dental Implant | Perioseal | DZE | Class II | |
| K972861 | Il Test Contril Spectrum (Levels 1, 2 and 3) | Instrumentation Laboratory Co. | JJS | Class I | |
| K972371 | Icel Ultrasonic Nebulizer Models Pu 12000 Air and Pu 12300 Air | Brasamerica Medical Equipment, Inc. | CAF | Class II | |
| K971870 | Lactosorb Trauma Plating System | Zimmer GmbH | HRS | Class II | |
| K971519 | Asserachrom Tpa Test Kit | American Bioproducts Co. | GGP | Class II | |
| K971222 | Cryo Check Apc Resistant Plasma | Precision Biologicals, Inc. | GGN | Class II | |
| K970611 | Origin Cardiac Stablizer Occluder | Origin Medsystems, Inc. | DXC | Class II | |
| K965178 | Niagara Dual Lumen Catheter | Vas-Cath, Inc. | MPB | Class II | |
| K964229 | Regulus Navigator | Compass Intl., Inc. | HAW | Class II | |
| K972683 | V-Delta 450 | Metalor Dental USA Corp. | EJS | Class II | |
| K972322 | Lorenz 1.5 Mm Neuro Pack/lorenz 2.0 Ft Plates | Biomet Microfixation | JEY | Class II | |
| K972029 | Bicon Dental Implants II Part Abutment System | Bicon, LLC | DZE | Class II | |
| K971874 | Sharplan Epitouch Alexandrite Laser System (5000) | Sharplan Lasers, Inc. | GEX | Class II | |
| K971860 | Medisystems Dialysis Priming Sets | Medisystems Corp. | KOC | Class II | |
| K971859 | Earcheck | Mdi Instruments, Inc. | ETY | Class II | |
| K971855 | Potty Pal and Forever-Dry | Digital Applications, Inc. | KPN | Class II | |
| K971500 | Access Systems Needleless Vial Adapter | Biological & Environmental Control Laboratories | FPA | Class II | |
| K971271 | Besecure External Urinary Collection System | Urology Research Intl., Inc. | KNX | Class II | |
| K970943 | Guideline System | Axon Instruments, Inc. | GZL | Class II | |
| K970182 | Dinamap Compact Monitor | Johnson & Johnson MEDICAL GmbH | MHX | Class II | |
| K970129 | Tulip | Richard Ting | ELW | Class II | |
| K965140 | Cardiometrics Wavewire/wavemap Pressure System | Cardio Metrics, Inc. | DQX | Class II | |
| K964689 | Traccell 2000 Slide Mapping System | Accumed Intl., Inc. | JOY | Class II | |
| K961942 | Epidural Peg Electrode (Ep), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (Ed-Fo) for Epilepsy Monitori | Radionics, Inc. | GYC | Class II | |
| K954758 | Rootform Dental Implant System | Swiss Dental Center | DZE | Class II | |
| K972838 | Powder-Free Nitrile, Poly-Coated Examination Glove, Purple or White (Non-Colored) | Absolute Synthetic Technologies Malaysia Sdn. Bhd. | LZA | Class I | |
| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme Immunoassay | Dade Intl., Inc. | JHX | Class II | |
| K972710 | Quantify(901) | Hematronix, Inc. | JJW | Class I | |
| K972674 | Wilson-Cook Needle Knife Papillotome | Wilson-Cook Medical Inc. | KNS | Class II | |
| K972632 | Vera Pd Solder | Aalba Dent, Inc. | EJT | Class II | |
| K972536 | Syringe Needle Remover (S.n.r.) | Post Medical, Inc. | FMI | Class II | |
| K972532 | Aalba Gold Solder | Aalba Dent, Inc. | EJT | Class II | |
| K972465 | Aloka Ssd-1400 Diagnostic Ultrasound System | Aloka Co., Ltd. | IYN | Class II | |
| K972369 | Sealapex | Sybron Dental Specialties, Inc. | KIF | Class II | |
| K972363 | Il Test Iron | Instrumentation Laboratory Co. | JIY | Class I | |
| K972276 | Cerec 2 Crown Software | Siemens Corp. | ELW | Class II | |
| K972173 | Medi-Sis Syringe Infusion System | Halyard Health | MEB | Class II | |
| K972152 | Devmed Stepping and Stabilizing System | Devmed Corp. | ITX | Class II | |
| K972118 | Vera Pdn | Aalba Dent, Inc. | EJH | Class II | |
| K972107 | Minimed Infusion Pump, Model 507C | Medtronic, Inc. | LZG | Class II | |
| K972106 | Phonak Novo Forte E3 | Phonak, Inc. | ESD | Class I | |
| K972104 | Lightly Powdered Vinyl Synthetic Examination Gloves | Shinemound Enterprise, Inc. | LYZ | Class I |