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 |
|---|---|---|---|---|---|
| K971361 | Aq Opiates (Morphine) Test | Bionike Laboratories, Inc. | DJG | Class II | |
| K971303 | Instead, Softcup | Ultrafem, Inc. | HHE | Class II | |
| K971299 | Scientific Plastics Model Sp | Scientific Plastics, Inc. | ESD | Class I | |
| K971244 | Provox 2 Voice Prosthesis System | Atos Medical AB | EWL | Class II | |
| K971240 | Alexander Manufacturing Co. Rechargeable Battery Part Number M006 | Alexander Mfg. Co. | HEL | Class II | |
| K971143 | Neuro Pulse Ii,iii | Apyx Medical Corporation | ETN | Class II | |
| K971080 | Maico Ma52 | Bernafon-Maico, Inc. | EWO | Class II | |
| K971016 | Mrp-7000/Airis Qd C-Spine Coil (P/n Mr-Qcsc-42,Mr-Qcsc-52) | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K970939 | Vista V-38 Cic | Vista Labs | ESD | Class I | |
| K970880 | Power D, Tru 5, Persona, Persona Choice, Meridian | Micro-Ear Technology, Inc. | ESD | Class I | |
| K970868 | Model Hnc Neurovascular Array Coil | Mri Devices Corp. | MOS | Class II | |
| K970735 | Boehringer Mannheim Direct Hdl-Cholesterol | Randox Laboratories, Limited | LBS | Class I | |
| K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | DQX | Class II | |
| K970324 | Gsi Sa60 Dpoae System | Grason-Stadler, Inc. | ETW | Class II | |
| K964634 | Anokryo | Mk Conquest Intl., Inc. | FFP | Class I | |
| K964396 | Double Up Breast Pump | The Natural Choice Co., Inc. | HGX | Class II | |
| K964042 | Extresafe Phlebotomy | Specialized Health Products, Inc. | FMI | Class II | |
| K963748 | Bio-Plexus Drop-It Needle Holder | Bio-Plexus, Inc. | FMI | Class II | |
| K954142 | Sterradd Sterilization System | Advanced Sterilization Products | FLE | Class II | |
| K971272 | Trauma-Fix External Fixator | Trend Medical, LLC | KTW | Class II | |
| K971235 | Alexander Manufacturing Co. Rechargeable Battery Part Number Gl625-W | Alexander Mfg. Co. | DQA | Class II | |
| K971135 | Magellan Intramedullary Femoral Nail System | Wrightmedicaltechnologyinc | HSB | Class II | |
| K971107 | Alexander Manufacturing Co. Rechargeable Battery Part Number Str5 | Alexander Mfg. Co. | BTA | Class II | |
| K971099 | Alexander Manufacturing Co. Rechargeable Battery Part Number Ms5169 | Alexander Mfg. Co. | HGM | Class II | |
| K970852 | Magnetom Project 024 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K970846 | 22.2/+4Mm Co Cr & Zirconia Femoral Head | Landos, Inc. | LZO | Class II | |
| K970843 | Intergard Woven Collagen Coated Vascular Prostheses | Intervascular, Inc. | DSY | Class II | |
| K970816 | Glare Ware | Ergovision, Inc. | HQY | Class I | |
| K970153 | Lamin-2 Hydrating Gel | Procyte Corp. | MGQ | Unclassified | |
| K965180 | Straightfire Reusable Optical Fibers (400,600,800,1000) | Myriad Lase, Inc. | GEX | Class II | |
| K964067 | Gore Irrigation Set | W. L. Gore & Associates, Inc. | FPA | Class II | |
| K963064 | Ano-Rectal Manometry Option, Model Number Uds-Arm | Laborie Medical Tech Corp. | FFX | Class II | |
| K971603 | Sterile Sureflex Files and Instruments | Dentsply Intl. | EFA | Class I | |
| K971575 | Benchmark-IV | J.F. Jelenko & Co., Inc. | EJT | Class II | |
| K971551 | Duqiao | Duqiao Glasses (Group) Co., Ltd. | HQY | Class I | |
| K971465 | National Medical Halthcare Custom Ophthalmic Kits or Trays | National Healthcare Mfg. Corp. | HOY | Class I | |
| K971424 | Dermaclean X-Am (Protein Labeling Claim) Examination Gloves | Ansell Perry | LYY | Class I | |
| K971350 | Series Xe, Series Se, Series Te | Micro-Mega Societe Anonyme | EGS | Class I | |
| K971220 | Greiner Vacuette Blood Collection Tube | Greiner America, Inc. | JKA | Class II | |
| K971066 | Tamaryn i.v. Flow Regulator Extension Set | Tamaryn Medical Systems, Inc. | FPA | Class II | |
| K970905 | Synchron Cx Systems Lipase (Lipa) Reagent | Beckman Instruments, Inc. | CHI | Class I | |
| K970865 | Isg Family of Viewing Wands | I.S.G. Technologies, Inc. | HAW | Class II | |
| K970578 | Radionics Burr Hole Valve | Radionics, Inc. | JXG | Class II | |
| K970506 | Hilux 200,250,275,300,350,500 Dental Curing Light | Benlioglu Dental Ithalat, Inc. | EBZ | Class II | |
| K970497 | Pace 101H | Sulzer Oscor, Inc. | DTE | Class II | |
| K970386 | Acs Estadiol-6 II | Chiron Diagnostics Corp. | CHP | Class I | |
| K970339 | Tri Auto Zx | J. Morita USA, Inc. | EKX | Class I | |
| K965137 | Fogarty Valvulotome Model 700091 | Baxter Edwards | MGZ | Class II | |
| K965062 | Siemens Sc9000/sc9015 Multigas and Multigas+ Modules | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K964660 | Paramax Cholesterol Reagent | Dade Intl., Inc. | CHH | Class I |