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 |
|---|---|---|---|---|---|
| K950126 | Endoscopic Ligation Device, Ligator Handle, Ligator Cartridge | Advanced Surgical, Inc. | GCJ | Class II | |
| K946340 | Beltone Comparafit | Beltone Electronics Corp. | ESD | Class I | |
| K945610 | Abusign(tm) Amp, Doa-Amp, Accusign(tm) Amp-Doa-Amp, Biosign(tm) Amp, Doa-Amp | Princeton BioMeditech Corp. | DKZ | Class II | |
| K945398 | Branemark System(r) Mkii Self-Tapping Fixture | Nobelpharma USA, Inc. | DZE | Class II | |
| K944188 | Spinal Marker | Leibinger GmbH | LXH | Class I | |
| K943240 | Flexiflo Six Enteral Nutrition Pump Set | Abbott Medical | KNT | Class II | |
| K942799 | Datum | Blease USA, Inc. | CAD | Class II | |
| K942374 | Allure (Methafilcon a) Soft (Hydrophilic) Daily Wear Contact Lens | Sunsoft Corp. | LPL | Class II | |
| K942359 | Bone Plate System | Acu Med, Inc. | HRS | Class II | |
| K936266 | Comfit Pink Powdered Examination Gloves (Hypoallergenic) | Wembley Rubber Products (M) Sdn Bhd | LYY | Class I | |
| K935466 | Clinical Voice Thermometer | Blazie Engineering, Inc. | FLL | Class II | |
| K950983 | Imedge Digita Otoscope or Digital Video Otoscope | Introspect, Inc. | ERA | Class I | |
| K950343 | Hyperpacs Pacs and Telerafiology System | Rogan Imaging Corp. | LMD | Class I | |
| K950069 | Dasher-14 | Target Therapeutics | DQX | Class II | |
| K945828 | Echo Planar Imaging I | Philips North America LLC | LNH | Class II | |
| K945292 | Ts-700P Control Xp Electrical Stimulator | Myo/Kinetic Systems, Inc. | KPI | Class II | |
| K945130 | Braemar Model Dl700 Ambulatory Electrocardiographic Recorder | Braemar Manufacturing, LLC | DSH | Class II | |
| K943537 | Model 3470 X-Trel RF Receiver | Medtronic, Inc. | GZB | Class II | |
| K940323 | Arbo Diagnostic ECG Patient Cables & Leadwires Arbo Shielded Multi-Lead Cable & Lead System | Arbo Medical, Inc. | DSA | Class II | |
| K940081 | Mercury | Mennen Medical, Inc. | DRT | Class II | |
| K951437 | Oti Model Tls-60 | Oti Medical, LLC | HPC | Class I | |
| K950971 | Mobil C-Arm, Regurbished, Various Models | Pro-Tronics, Inc. | JAA | Class II | |
| K950570 | Stratus Progesterone Fluorometric Enzyme Immunoassay | Baxter Diagnostics, Inc. | JLS | Class I | |
| K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | JJY | Class I | |
| K946358 | Endoscopic Biliary Catheter | Boston Scientific Corporation | LQR | Class II | |
| K946245 | Tielle* Hydropolymer Dressing | Johnson & Johnson International | KMF | Class I | |
| K945199 | Rh2000 Real Ear Measurement System | Madsen Electronics, Inc. | EWO | Class II | |
| K944759 | 200 Series Gastro-Intestinal Video System | FUJIFILM Healthcare Americas Corporation | FET | Class II | |
| K943966 | Vivapore 2 | Vivascience, Inc. | JJH | Class I | |
| K943965 | Vivapore 10 | Vivascience, Inc. | JJH | Class I | |
| K943448 | Lumin | Utah Medical Products, Inc | LKF | Class II | |
| K941435 | Bipolar U-Shape Handle, Prongs, and Cord | New Eder Corp. | GEI | Class II | |
| K940112 | X-Ray Film Processor | Fischer Industries, Inc. | IXW | Class II | |
| K924523 | Hys-Surgiflator | Novanta Medical GmbH | HIG | Class II | |
| K951387 | Symbiosis Bipolar Scissors | Boston Scientific Corporation | GCJ | Class II | |
| K951340 | Neitz Slit Lamp Sl-H1 | Neitz Instruments Company, Ltd. | HJO | Class II | |
| K951265 | Monoject Diamond Point Spinal Needle (28G X 3 1/2) | Sherwood Medical Co. | BSP | Class II | |
| K951249 | Citation Sinuscope | Citation Medical Corp. | EOB | Class II | |
| K951237 | Algi-Band | Health-Dent Intl., Inc. | ELW | Class II | |
| K951199 | Fb-18X, Fiber Bronchoscope | Pentax Precision Instrument Corp. | EOQ | Class II | |
| K951120 | Sun-Burst | Kid'S Wheel-Chairs | IOR | Class I | |
| K951004 | 2001 Special Procedure Lamp (Low Voltage) (as Exhibits #2 & 4) | Kenex, Ltd. | KPY | Class I | |
| K950945 | Cooper Laser Sonics Cusa Model 200 | Medtronic, Inc. | LFL | Unclassified | |
| K950905 | C&b-Metabond Radiopaque Powder | Parkell, Inc. | KLE | Class II | |
| K950873 | Cardon Physical Therapy Tables Models: R27622 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K950287 | Univit Probe | Medical Instrument Development Laboratories, Inc. | HKP | Class II | |
| K950115 | Luhr(r) Titanium Burr Hole Covers | Howmedica Corp. | HRS | Class II | |
| K950105 | Luhr(r) Titanium Alloy Burr Hole Covers | Howmedica Corp. | HRS | Class II | |
| K950102 | Human C-5 Radial Immunodiffusion Kit | Kent Laboratories, Inc. | DAY | Class II | |
| K946234 | Osteonics(r) Restoration Monolithic II Hip Stem Series | Osteonics Corp. | MEH | Class II |