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 |
|---|---|---|---|---|---|
| K073568 | Psl Biozir Block | P.S.L. International, Inc. | EIH | Class II | |
| K073224 | Oral-B Sub-Brand Manual Toothbrush | Procter & Gamble Co. | EFW | Class I | |
| K073110 | Merits E600 Series Stair Lift | Merits Health Products, Inc. | ILK | Class II | |
| K072899 | Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0 | Aesculap Inc | HAW | Class II | |
| K072656 | Dynasty Ceramic Femoral Head | Wrightmedicaltechnologyinc | LZO | Class II | |
| K072412 | Option Smartcare for Evitaxl,smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500 | Drager Medical AG & Co. KGaA | CBK | Class II | |
| K071148 | Atlas Implant System | Cowellmedi Co., Ltd. | DZE | Class II | |
| K062798 | Smart Nitinol Self-Expanding Stent, Model C06120mb, C07120mb, C08120mb, C06150mb, C07150mb, C08150mb | Cordis US Corp. | FGE | Class II | |
| K080091 | Modification To:health Buddy Appliance | Health Hero Network, Inc. | DRG | Class II | |
| K080016 | Nrbc-Chex for Advia | Streck LLC | GJR | Class II | |
| K073626 | Bio-Logic Master II Evoked Response System | Bio-Logic Systems Corp. | GWJ | Class II | |
| K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics GmbH | NBC | Class II | |
| K072254 | Vn415m, Vn415b, Vo425m, V0425b, 2D-Vog Goggles, 2D-Vog System | Interacoustics a/S | GWN | Class II | |
| K072189 | Pathfast Ntprobnp and D-Dimer Tests | Mitsubishi Kagaku Iatron | NBC | Class II | |
| K073554 | Neun | Kulzer GmbH | EBF | Class II | |
| K073531 | Accin Pedicle Screw System | Accelerated Innovation, LLC | MNH | Class II | |
| K073521 | Musmate Walking Aid | Musmate, Ltd. | OHI | Class I | |
| K073319 | Statmatic 31 Handpiece Maintenance Unit | Scican Ltd. | EFB | Class I | |
| K072959 | Ms System (Denture) | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K072908 | Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy | Gambro Renal Products | KPO | Class II | |
| K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot | Medacta International SA | JDI | Class II | |
| K080106 | Skintact Pre-Wired ECG Electrodes with Conductive Adhesive | Leonhard Lang GmbH | DRX | Class II | |
| K073651 | Neotract Anchor System | Neotract Inc | GAT | Class II | |
| K073457 | Mstar Mpd4500 | Xinaomdt Technology Co., Ltd. | LNH | Class II | |
| K073200 | Gandras Intravascular Catheter, Models 5580, 5581 and 5582 | Vascular Solutions LLC | DQO | Class II | |
| K072889 | Human Igg Subclass Liquid Reagent Kits for Use on the Spaplus Analyser | The Binding Site | CFN | Class II | |
| K072270 | Diazyme Cystatin C: Assay Kit (Dz133a-K), Calibrator (Dz133a-Cal), Controls (Dz133a-Con) | Diazyme Laboratories, Inc. | NDY | Class II | |
| K072123 | Homewave Neuromodulations Pain Therapy Device | Biowave Corporation | GZJ | Class II | |
| K072093 | Prismaflex System, Version 3.20 | Gambro, Inc. | KDI | Class II | |
| K072018 | Bs-200 Chemistry Analyzer, Mode Bs-200 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | CFR | Class II | |
| K071866 | Ntrainer System | Kcbiomedix, Inc. | HCC | Class II | |
| K071199 | Bonalive Granules | Vivoxid, Ltd. | MQV | Class II | |
| K071149 | Hri 6500, 6600 and 6700 Series V2masks | Hans Rudolph, Inc. | BZD | Class II | |
| K070985 | Aesculon Chf, Hypertension & Pacemaker Clinic | Osypka Medical GmbH | DSB | Class II | |
| K063350 | Dual-Cannula System Acc. Mancao, Special Sprotte | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K053527 | Spectra Hair Removal Laser | Spectragenics, Inc. | GEX | Class II | |
| K080124 | Ventri 1.1 | GE Medical Systems F.I. Haifa | KPS | Class II | |
| K080121 | Cynosure Smartlipo Multiwavlength Laser | Cynosure, LLC | GEX | Class II | |
| K073563 | Modification to Proxis System | Abbott Medical | NFA | Class II | |
| K073559 | 18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula II | Edwards Lifesciences LLC | DQR | Class II | |
| K073539 | Provisa Cem | Cavex Holland B.V. | EMB | Class I | |
| K073530 | Accin Anterior Cervical Plate System | Accelerated Innovation, LLC | KWQ | Class II | |
| K073171 | Resuscitation Timer, Model L770-CPR | Allied Medical LLC | BTM | Class II | |
| K072920 | Handheld Base Unit | Roche Diagnostics GmbH | GJS | Class II | |
| K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | LIT | Class II | |
| K072691 | Cervical Md, Model C10 | Sti Medical Systems | HEX | Class II | |
| K072363 | Nanotite Prevail,certain,parellel Walled,tapered,external Hex | ZimVie US Corp LLC | DZE | Class II | |
| K072002 | Filter Carestar 30; Filter Safestar 55; Filter/hme Twinstar 55 | Draeger Medical AG & Co. KG | CAH | Class II | |
| K071646 | Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model # S-04-040-120 | Idev Technologies, Inc. | FGE | Class II | |
| K073707 | Ge Datex-Ohmeda Aisys | GE Healthcare | BSZ | Class II |