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 |
|---|---|---|---|---|---|
| K920662 | Vascotwist 9/60 | Vascor Medical Corp. | DTB | Class III | |
| K914544 | Bd6000 the Optima & Bd5000 Birthing Bed | Lic Care, Inc. | KNC | Class II | |
| K934254 | Impulse 3000 Defibrillator Analyzer | Dynatech/Nevada, Inc. | DRL | Class II | |
| K934123 | Stopcock (One-Port Manifold) | Merit Medical Systems, Inc. | DTL | Class II | |
| K933508 | Reflex Sdd Surgical Stapler | Richard-Allan Medical | GEF | Class I | |
| K931486 | Intrex Vsk Interoral Dental X-Ray Unit | Keystone X-Ray, Inc. | EAP | Class II | |
| K931457 | Ndm Silvon ECG Electrodes | Ndm Acquisition Corp. | DRX | Class II | |
| K925629 | Accessory to Improved Dental Operating Light | Den-Tal-Ez Mfg Co., Inc. | EAZ | Class I | |
| K934935 | Eclipse Lazerblade(tm) Fiberoptic Delivery System | Cardiogenes | GEX | Class II | |
| K934869 | Stc Diagnostics Auto-Lyte Benzodiazepines Eia | Solarcare Technologies Corp,Inc. | JXM | Class II | |
| K934850 | Nuclear Associates Personnel Protective Shields | Victoreen, Inc. | KPX | Class II | |
| K934769 | Argelite W | Argen Precious Metals, Inc. | EJT | Class II | |
| K934705 | Opus Napa | Pb Diagnostic Systems, Inc. | LAN | Class II | |
| K934693 | Amphetamine Test System | U.S. Drug Testing, Inc. | DKZ | Class II | |
| K934683 | R and D Bateries | R & D Batteries, Inc. | FCO | Class I | |
| K934100 | Remel Cefprozil 30 Mcg Susceptibility Disk | Remel Inc | JTN | Class II | |
| K933997 | Prospect Entamoeba Histolytica Microplate Assay | Alexon Biomedical, Inc. | GMD | Class II | |
| K933835 | 0.5T Asset System | Philips North America LLC | LNH | Class II | |
| K933791 | Philips Angiopro Release 2.1 | Philips North America LLC | JAA | Class II | |
| K933715 | Boston Scientific Corporation Side Firing Laser Guide | Boston Scientific Corporation | GEX | Class II | |
| K933711 | E-Sp Combined Epidural-Spinal Anesthesia Tray | Neurodelivery Technology, Inc. | CAZ | Class II | |
| K933659 | Model #100Ge1500 Lower Extrem Quad Detect Array Coil | Medic, Inc. | LNH | Class II | |
| K933536 | Carter-Thomason Needle-Point Suture Passer | Neimark Labs, Inc. | GCJ | Class II | |
| K933478 | Technicon H*1 Systems, Labfacts Software for U.i.w. Versions 4.11 & 5.11 | Miles, Inc. | GKZ | Class II | |
| K933475 | Technicon H* 2 System, Labfacts Software for U.i.w. Versions 4.11 & 5.11 | Miles, Inc. | GKZ | Class II | |
| K933247 | Protective Sheath for Flexible Nasophary/larygnos | Cogentix Medical, Inc. | EOB | Class II | |
| K932836 | Nidek Model Ac-2300 | Nidek, Inc. | HQF | Class II | |
| K932392 | Phx Technologies Corp Electrosurgical Probes | Phx Technologies Corp. | GEI | Class II | |
| K932372 | Cemax Vipstation(tm) And/or Software | Cemax, Inc. | LLZ | Class II | |
| K931839 | Rota System Xl | Rota Systems Medfurniture, Inc. | HMF | Class I | |
| K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | GCJ | Class II | |
| K931544 | 1.5T Edge and 1.0T Vista Systems | Philips North America LLC | LNH | Class II | |
| K931186 | Photophone Multiview | Image Data Corp. | LMD | Class I | |
| K930703 | Adjustable Bed | Maxwell Products, Inc. | FNL | Class II | |
| K930266 | Vinyl Examination Gloves | Shanghai PM Plastics Enterise Co., Ltd. | LYZ | Class I | |
| K926452 | Zeiss Visulas Yag II Laser | Carl Zeiss, Inc. | GEX | Class II | |
| K925726 | Alloy Scalpel Handpieces, Modification | Lca, Inc. | GEX | Class II | |
| K924977 | Codman Laser Neuroendoscope | Cerenovus, Inc. | GWG | Class II | |
| K924376 | Root Canal Post | The Thera Group | EBL | Class I | |
| K934755 | Fast Find Grind | Webb Research Ii, Inc. | KPR | Class II | |
| K934626 | Goodall Laser Targeting Device | Protectair, Inc. | JAA | Class II | |
| K934618 | Otosonic Advanced Full Shield (Afs) | Beltone Electronics Corp. | ESD | Class I | |
| K934597 | Clarifier II Circuit Option | Miracle-Ear, Inc. | ESD | Class I | |
| K934586 | Programmable Air Conduction Behind the Ear Hearing Aid | Unitron Industries, Inc. | ESD | Class I | |
| K934480 | Rionet Hearing Aid Ha-73 | Authorized Hearing Systems, Inc. | ESD | Class I | |
| K934479 | Rionet Hearing Aid Ha-72 | Authorized Hearing Systems, Inc. | ESD | Class I | |
| K934391 | V/p and L/p Catheter Passers | Radionics, Inc. | GYK | Class I | |
| K934193 | Cell-Mate(tm) Mass Cytology-Cellular Retrieval Syst | Biosearch Medical Products, Inc. | EOX | Class II | |
| K933901 | Reflex(r) Ehs (Endoscopic Hernia Stapler) | Richard-Allan Medical | GAG | Class II | |
| K933658 | Model 300Ge1500 Shoulder Coil | Medic, Inc. | LNH | Class II |