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 |
|---|---|---|---|---|---|
| K003451 | Denver Pak W/ Double-Valve Ascites Shunt,denver Pak W/ Single-Valved Ascites Shunt, Denver Pak, Doubled-Valved Ascites T | Denver Biomedicals, Inc. | KPM | Class II | |
| K003441 | Castle Model 233Hc Steam Sterilizer | Getinge/Castle, Inc. | FLE | Class II | |
| K992424 | Seldiflex Long-Term Central Venous Catheter(40cm & 60Cm in Length), Models 63244J20 & 63246J20 | Plastimed Laboratoire Pharmaceutique | LJS | Class II | |
| K003240 | Biomet External Wrist Plate | Zimmer GmbH | LXT | Class II | |
| K002182 | Avita Tso/ts1 Infrared Ear Thermometer | Avita Corporation | FLL | Class II | |
| K002127 | Injectrite-C15 and Injectrite-C30 | Sterling Medivations, Inc. | FMF | Class II | |
| K003386 | Special Procedures Head Coil; Model # 1100Ge-64 | Midwest Rf, LLC | MOS | Class II | |
| K003212 | Fixion Intramedullary Nailing System (Fixion Im Nail) | Disco-O-Tech Medical Technologies, Ltd. | JDS | Class II | |
| K003097 | Brain Coil, Model 9800Ge-64 | Midwest Rf, LLC | MOS | Class II | |
| K003040 | Intrastent Protege Self-Expanding Nitinol Stent with Starport Delivery Technology | Intratherapeutics, Inc. | FGE | Class II | |
| K001576 | Eva -Vacuum Assist Device for Clitoral Therapy | Prosurg, Inc | NBV | Class II | |
| K003815 | Travel Ease Electric Scooter, Model Pioneer | Merits Health Products, Inc. | INI | Class II | |
| K003739 | Aloka Ssd-4000 | Aloka Co., Ltd. | IYN | Class II | |
| K003643 | Numed Z-Med Ptv Catherers | Numed Inc | DQY | Class II | |
| K003568 | Xiscan 6000 Imaging System | Xitec, Inc. | OXO | Class II | |
| K003516 | Gyroscan Intera 3.0T | Philips North America LLC | LNH | Class II | |
| K003230 | V Score with Auto Gate Model Tbd | Canon Medical Informatics, Inc. | JAK | Class II | |
| K003215 | Modification of Fixion Intramedullary Nailing System (Fixion Im Nail) | Disco-O-Tech Medical Technologies, Ltd. | JDS | Class II | |
| K003175 | Compumedics Siesta System | Compumedics Limited | OLV | Class II | |
| K002830 | Pelvic Muscle Therapy | Colonial Medical Supply | HIR | Class II | |
| K002803 | The O'neil Sterile Field Urinary Catheter Kit | Go Medical Industries Pty., Ltd. | FCM | Class II | |
| K002197 | Cartouch | Cardionics, Inc. | DPS | Class II | |
| K002031 | Phacofragmentation System Megatron | Asclepion-Meditec AG | HQC | Class II | |
| K001785 | Surgisis Peripheral Vascular Patch | Cook Biotech, Inc. | DXZ | Class II | |
| K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | Depuy Orthopaedics Inc. | FTM | Class II | |
| K001499 | Phormax Eagle Scanner System | Phormax Corp. | MQB | Class II | |
| K000396 | Apnoescreen Pro, Alpha Screen Pro | Erich Jaeger, Inc. | MNR | Class II | |
| K003677 | Abx Pentra 60C+ Hematology Analyzer | Horiba Instruments Incorporated | GKZ | Class II | |
| K003372 | Immulite High Sensitivity Crp, Immulite 2000 High Sensitivity Crp | Siemens Healthcare Diagnostics Inc. | DCN | Class II | |
| K003050 | Cryosurgical Unit and Accessories | Cryogen, Inc. | GEI | Class II | |
| K994279 | Pure Water-Cds (Central Dialysis Solution) | Pure Water Solutions, Inc. | FIP | Class II | |
| K003849 | Ge Advance Nxi Pet System | GE Healthcare | KPS | Class II | |
| K003790 | Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 | Davol, Inc. | GCJ | Class II | |
| K003769 | Encore Microptic Powder Free Latex Surgical Gloves, Model 87 | Ansell Healthcare Products LLC | KGO | Class I | |
| K003687 | Verdict II Thc/coc/opi/amp, Verdictii Thc/coc/opi,verdict II Thc/coc/amp,verdict II Thc/coc/pcp,verdict II Thc/coc | MEDTOX Diagnostics, Inc. | DKE | Class II | |
| K003685 | Model 342Ge-64 High Resolution Brain Coil | Medical Advances, Inc. | MOS | Class II | |
| K003635 | Dw 276 #3 | Ivoclar North America, Inc. | EJT | Class II | |
| K003366 | Model 545Ph Series: Phased Array Musculo-Skeletal Flex Coil | Igc-Medical Advances, Inc. | MOS | Class II | |
| K003305 | Pediatric Ingestascan | Adams Electronics, Inc. | HPM | Class II | |
| K003270 | Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067 | Nucletron BV | JAQ | Class II | |
| K003265 | Cleanair/ Cleanwater Unit, Model 1600 | Texas Institute for Conservative Dentistry | EIA | Class I | |
| K003257 | Ehc400 Desktop Patient Station; Ech600 Care Provider Station | Cybercare Technologies, Inc. | CGA | Class II | |
| K003196 | Synchron Systems Ammonia Reagent | Siemens Healthcare Diagnostics Inc. | JIF | Class I | |
| K003134 | Foam Calcium Alginate Topical Wound Dressing | Adri/Technam | KGN | Unclassified | |
| K003036 | Turbo-Flow Infusion Cannula 19 Gage,20 Gage,23 Gage, 25 Gage, Model 101019,101020,101023,101025 | Retinalabs.Com | KYG | Class I | |
| K002976 | Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401Xxx and 401Xxx | Abbott Medical | DRF | Class II | |
| K002449 | Bioteq i.v. (Intravenous) Set | Bioteque Corp. | FPA | Class II | |
| K001955 | Aaron 1250 High Frequency Electrosurgical Generator, Model A1250 | Apyx Medical Corporation | GEI | Class II | |
| K000641 | Cd Horizon Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K991093 | Msd Embolectomy Basket | Metamorphic Surgical Devices, LLC | QEW | Class II |