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 |
|---|---|---|---|---|---|
| K003732 | Braun Precision Sensor, Model Bp 2000 Series | Braun GmbH | DXN | Class II | |
| K003712 | Modification to Male to Male Luer Adapter | Molded Products Inc | KOC | Class II | |
| K003707 | Cardionet Ambulatory ECG Monitor, Model Cn1000a | Cardionet, LLC | MWJ | Class II | |
| K003609 | N-Mid Osteocalcin One Step Elisa Model 30Sc4000 | Osteometer Biotech A/S | NEO | Class II | |
| K003086 | Concentric Micro Catheter, Models 90001 to 90008 | Concentric Medical, Inc. | DQO | Class II | |
| K003084 | Concentric Hydrophilic Guidewire, Models 90011, 90012 | Concentric Medical, Inc. | DQX | Class II | |
| K002037 | Lifecore Biomedical Dental Implant Systems | Lifecore Biomedical LLC | DZE | Class II | |
| K011315 | Ssd 5500 with Olympus Gf Type Uc140p-Al5 | Aloka Co., Ltd. | IYN | Class II | |
| K011314 | Olympus Gf Uc140p-Al5 Ultrasonic Endoscope with Aloka Ssd-5500 Ultrasound System | Aloka Co., Ltd. | ITX | Class II | |
| K011289 | Emit II Plus Opiate Assay, Model Osr9b229 | Syva Co., Dade Behring, Inc. | DJG | Class II | |
| K011268 | Breezy Wheelchair, Model 300 | Sunrise Medical, Inc. | IOR | Class I | |
| K011161 | Modification to the Emit II Plus Phencyclidine Assay, Model Osr9j229 | Syva Co., Dade Behring, Inc. | LCM | Unclassified | |
| K011151 | Evis Exera Gastrointestinal Videoscope Gif-Q160z | Olympus Optical Co., Ltd. | FDS | Class II | |
| K011149 | Disposable Bending Cannula Pr-233Q | Olympus Optical Co., Ltd. | ODD | Class II | |
| K011038 | Taper-Lock Dental Implant System | Sulzer Dental, Inc. | DZE | Class II | |
| K010948 | Dynatron Sts Rx | Dynatronics Corp. | LIH | Class II | |
| K010917 | Power Tilt and Recline System | Sunrise Medical, Inc. | ITI | Class II | |
| K010855 | Randox Ige | Randox Laboratories, Limited | DGC | Class II | |
| K010566 | Colleague Volumetric Infusion Pump | Baxter Healthcare Corporation | FRN | Class II | |
| K010565 | Dynatron Sts | Dynatronics Corp. | LIH | Class II | |
| K001699 | Rubicon Prothrombin Time Monitoring System | Lifescan, Inc. | GJS | Class II | |
| K001694 | Guidant Retriever Device | Guidant Cardiac and Vascular Surgery | DQY | Class II | |
| K011380 | Modification to the Bioplate Bioclip Craniotomy Fixation System | Bioplate Inc | JEY | Class II | |
| K011236 | Modification to Implantable Clip | Applied Medical Resources Corp | FZP | Class II | |
| K011107 | Modification to Solo | Ranger All Season Corp. | INI | Class II | |
| K010673 | Arthrex Fiberwire, Model Spu-02Nb-3800 | Arthrex GmbH | GAT | Class II | |
| K010519 | Magnum Flow Irrigation System | Scion Valley, Inc. | GCJ | Class II | |
| K010465 | Denstat | Elmed, Inc. | GEI | Class II | |
| K010460 | Lifelines Trackit | Lifelines Ltd. | OLV | Class II | |
| K010457 | Arthrex Twistloc Suture Anchor, Model Ar-1924 | Arthrex GmbH | MBI | Class II | |
| K010436 | Tempus 2000 Patient Monitor, Model 00-0001; Tempus Monitoring Station, Model 01-0011 | Remote Diagnostic Technologies Ltd. | DXH | Class II | |
| K010197 | Exel Secure Touch Safety (P.s.v.) Scalp Vein Set | Exelint International Co. | FPA | Class II | |
| K004012 | Impra Carboflo Eptfe Vascular Grafts | Impra, Inc. | DYF | Class II | |
| K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | DSK | Class II | |
| K011227 | Regal Mototrized 3 Wheeled Vehicle | Bruno Independent Living Aids, Inc. | ITI | Class II | |
| K011006 | Amyseat Tilt/recline Seating | Amysystems | ITI | Class II | |
| K010803 | Powder-Free Latex Examination Gloves-Blue Color | Hwa Teh Industrial Sdn. Bhd. | LYY | Class I | |
| K010552 | Cg-900P Fetal/maternal Monitor | Card Guard Scientific Survival, Ltd. | HGM | Class II | |
| K010470 | R & D 4K Retic | R & D Systems, Inc. | JPK | Class II | |
| K010395 | E-Power | Dalton Medical Corp. | ITI | Class II | |
| K004018 | Skingard Polycoat Glove | Top Quality Mfg., Inc. | LYY | Class I | |
| K003504 | Rt-Plus Modular Cemented Knee Components | Plus Orthopedics | KRO | Class II | |
| K003480 | Biofind | Bio-Scan, Inc. | GZO | Class II | |
| K003020 | Cardiac Function Laboratory; Pressure Interface; Pressure / Volume Catheter | CD Leycom | DQO | Class II | |
| K002639 | Bioknotless Anchor | Mitek Products | GAM | Class II | |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229 | Syva Co., Dade Behring, Inc. | KLS | Class II | |
| K011164 | Modification to the Emit II Plus Methaqualone Assay, Model Osr9q229 | Syva Co., Dade Behring, Inc. | KXS | Class II | |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model Osr9g229 | Syva Co., Dade Behring, Inc. | JXN | Class II | |
| K011084 | Mandrel Guidewire Assembly | Lake Region Mfg., Inc. | DQX | Class II | |
| K011036 | Rd-3008 | Kulzer GmbH | EJT | Class II |