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 |
|---|---|---|---|---|---|
| K955011 | Candela Hcs 2000 Uretheral Warmer Catheter | Candela Corporation | GEH | Class II | |
| K934183 | Bonutti Anchor | Apogee Medical Products, Inc. | MBI | Class II | |
| K960975 | 1-4F Infiniti Angiographic Catheter | Cordis US Corp. | DQO | Class II | |
| K960944 | Ppv Vaporizer (Modification) | Penlon, Ltd. | CAD | Class II | |
| K960254 | Silgel Topical Gel Sheet | Rofil Medical USA, Inc. | MDA | Class I | |
| K960187 | Cocaine Metabolite Eia Test | Diagnostic Reagents, Inc. | DIO | Class II | |
| K960070 | Numed Atrioseptostomy Catheter | Numed Inc | DQO | Class II | |
| K960046 | Surgical Dynamics 30K Working Channel Scope | Surgical Dynamics Ltd | HRX | Class II | |
| K955444 | Abbott Axsm Procainamide Assay | Abbott Medical | LAR | Class II | |
| K955076 | Safe Tee | Pearson Strach Medical | GCJ | Class II | |
| K960739 | V-1504 Vertical Platform Lift | Barnes,Richardson & Colburn | ING | Class II | |
| K960621 | Expandacell Instrument Wipe | Summit Medical, LLC | GEC | Class I | |
| K960481 | Soft Tissue Augmentation Tube | Tissue Technologies, Inc. | FTL | Class II | |
| K960456 | Denver Paracentesis Needle(60-1200) Denver Paracentesis Needle with Drainage Line(60-1100) Denver Paracentesis Tray | Denver Biomaterials, Inc. | KDD | Class I | |
| K960388 | Dynarex Non-Woven Sponge | Dynarex Corp. | EFQ | Unclassified | |
| K960387 | Urosprobe System, Model 1000 | Uros Corp. | GEH | Class II | |
| K960302 | Consensus Acetabular Shell, All Uhmwpe | U.S. Medical Products, Inc. | JDI | Class II | |
| K960276 | Wheelchair Elevator | Services Industriels Savaria, Inc. | ING | Class II | |
| K960215 | CPR Urethral Catheter Tray | Custom Pack Reliability | FCM | Class II | |
| K960214 | CPR Foley Cahteter Kit | Custom Pack Reliability | FCM | Class II | |
| K960212 | CPR Irrigation Tray | Custom Pack Reliability | KYZ | Class I | |
| K960174 | Unimark Midstream Pregnancy Test Stick | Biotech Atlantic, Inc. | LCX | Class II | |
| K960088 | True Triglyceride | Sekisui Diagnostics P.E.I. Inc. | CDT | Class I | |
| K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | GEX | Class II | |
| K960020 | Solo Band Ligator | Surcraft, LLC | FHN | Class II | |
| K955472 | Ace Humerus & Radius Plates | Ace Medical | HRS | Class II | |
| K954671 | The Freedom Bed | Probed Medical Technologies, Inc. | IKZ | Class II | |
| K954347 | 3I Standard Threaded Implant | ZimVie US Corp LLC | DZE | Class II | |
| K954136 | Matrix Microson 410 | Matrix Biokinetics, Inc. | IMI | Class II | |
| K953796 | Banks Hydro-Therapy Chair | Keith Products, Inc. | ILM | Class II | |
| K953277 | Shadow Medal Locator | Fatswith Intl., Inc. | HPM | Class II | |
| K952943 | Consensus All Poly Tibia | U.S. Medical Products, Inc. | JWH | Class II | |
| K960913 | Access Free T3 Assay | Bio-Rad Laboratories Inc. | CDP | Class II | |
| K960819 | Heliodent Ds | KaVo Dental Technologies, LLC | EAP | Class II | |
| K960801 | Selector Angiographic Catheter (Various Models) | North American Instrument Corp. | DQO | Class II | |
| K960274 | Orgentec Micro-Albumin Pin Eia Assay | Orgentec | JIR | Class I | |
| K960250 | Vacutainer Brand Plus Serum & Sst Tubes | Becton Dickinson Vacutainer Systems | JKA | Class II | |
| K960177 | P.e.g. Patient Care Kit | United States Endoscopy Group, Inc. | KNT | Class II | |
| K960115 | Hichem Bun/urea Reagent Kit | Elan Pharma, Inc. | CDQ | Class II | |
| K955811 | Auxiliary Patient Table/magnetom Open System | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K955795 | Multi-Centrifuge | Novonx, Inc. | GKG | Class II | |
| K955650 | Olympus Sd Series Snares | OLYMPUS Corporation of the Americas | FDI | Class II | |
| K955484 | Xenon Option to Prism 3000 | Philips North America LLC | KPS | Class II | |
| K954905 | Cb Diode/532 Laser System | Continuum Biomedical, Inc. | GEX | Class II | |
| K954879 | Percutaneous Replacement Gastrostomy Feeding Catheter Tray (Modification) | United States Endoscopy Group, Inc. | KNT | Class II | |
| K954691 | Access Radiology Teleradiology Image Acquisition & Distribution System | Access Radiology Corp. | LMD | Class I | |
| K954451 | Evis 140 System | OLYMPUS Corporation of the Americas | FET | Class II | |
| K954397 | Bidirectional Doppler W/waveform Display | Koven Technology, Inc. | DPW | Class II | |
| K953676 | Breeze Digital Inflation Device | Namic | MAV | Class II | |
| K953113 | Sbdx Mobile Fluoroscopy System | Cardiac Mariners, Inc. | JAA | Class II |