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 |
|---|---|---|---|---|---|
| K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | GEI | Class II | |
| K091778 | Vascutek Cobrahood Eptfe Vascular Grafts | Vascutek, Ltd. | DSY | Class II | |
| K091287 | Vs-Sense Test | Common Sense, Ltd. | CEN | Class I | |
| K091142 | Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | FTM | Class II | |
| K082723 | Grindguard | Grind Guard Technologies, LLC | MQC | Unclassified | |
| K092486 | Vortex Medical Angiovac Cardiopulmonary Bypass Circuit | Vortex Medical, Inc. | DWE | Class II | |
| K092458 | Proxcelan Cs-131Preloaded Strands, Model Pl-1, Proxcelan Cs-131 Preloaded Strands in 18 Guage Needles, Model Pl-2 | Isoray Medical, Inc. | KXK | Class II | |
| K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & Id Kit | Ortho-Clinical Diagnostics, Inc. | GNW | Class I | |
| K092285 | Portable Dosimeter Dose Verification System, Model Td-Rd-90 | Best Medical Canada, Ltd. | IYE | Class II | |
| K092027 | Carescape Monitor B850 | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex GmbH | MAI | Class II | |
| K091753 | Elvis Hsv Id and D3 Typing Test System | Ortho-Clinical Diagnostics, Inc. | GQL | Class II | |
| K091733 | Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model Vh-2500 | Maquet Cardiovascular LLC | GEI | Class II | |
| K091706 | Quattro Porcelain System | Dentsply International, Inc. | EIH | Class II | |
| K091705 | Primer Plus | Bisco Inc | KLE | Class II | |
| K091419 | Vicks Powershot Dry Throat & Mouth Relief | Procter & Gamble Co. | LFD | Unclassified | |
| K090762 | Leda | Quantel Derma GmbH | GEX | Class II | |
| K090377 | Sinus Quick Eb System | Neobiotech Co., Ltd. | DZE | Class II | |
| K090309 | Lagis Endoscopic Instruments | Lagis Enterprises Co, Ltd. | GEI | Class II | |
| K090304 | Waveon Wrx Bone Fixation System | Sonoma Orthopedic Products, Inc. | HRS | Class II | |
| K092537 | Digital X-Ray Sensor, Model E9539,e9505,e9502, E9540 | Toshiba America Electronic Components, Inc. | MUH | Class II | |
| K092519 | Syngo.x | Siemens AG Medical Solutions | LLZ | Class II | |
| K092405 | Mammosite Multi Lumen | Hologic, Inc. | JAQ | Class II | |
| K092310 | Seguin Annuloplasty Ring | Abbott Medical | KRH | Class II | |
| K092286 | Fox Sv Pta Catheter | Abbott Vascular | LIT | Class II | |
| K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (Mct) System | Corventis, Inc. | DSI | Class II | |
| K090869 | Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113Td | Medtronic Perfusion Systems | DWF | Class II | |
| K090811 | Inspira Hd, Model: Nl1000 | Samsung HME America, Inc. | KPS | Class II | |
| K083867 | Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind | Siemens Healthcare Diagnostics Inc. | CDZ | Class I | |
| K083270 | Wmt Composite Dbm | Wrightmedicaltechnologyinc | MQV | Class II | |
| K082040 | Minisilk Ft | El.en. Electronic Engineering SpA | ONF | Class II | |
| K092572 | Core*it Dual | Spident Co., Ltd. | EBF | Class II | |
| K092423 | Xpect Flu a & B | Thermo Fisher Scientific Oy | PSZ | Class II | |
| K091820 | Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System | Medrad, Inc. | NBW | Class II | |
| K091398 | Arthroscope | Orthopedic Sciences, Inc | HRX | Class II | |
| K091338 | Collasorb Collagen Wound Dressing | Hartmann-Conco, Inc. | KGN | Unclassified | |
| K090895 | EKG-Plus II Software | Bionet Co., Ltd. | LOS | ||
| K090456 | Insuflow | Lexion Medical, LLC. | HIF | Class II | |
| K083608 | Erbe Hybrid Knife | Erbe USA Inc | GEI | Class II | |
| K083582 | Sign Hip Construct (Shc), Model: 701 | Surgical Implant Generation Network (Sign) | KTT | Class II | |
| K092357 | Chitogauze,2 in X 2 In,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8Ply, 1 in X 4 in, 8Ply, Chitogauze, Packaging Strip, 1/2 | Hem Con Medical Technologies, Inc. | QSY | Unclassified | |
| K092307 | Imasight 4600 Digital Radiography Sensor | Imasight, Inc. | KPR | Class II | |
| K092102 | Nordicbrainex Software, Version 1.0 | Nordicimaginglab AS | LLZ | Class II | |
| K092004 | Ge Innova Solid State XRAY-Imager Fluoroscopic X-Ray System, Model: 4100Iq, 3100Iq, 2100Iq | GE Healthcare | OWB | Class II | |
| K091897 | Blood Pressure Monitor, Model Fora P11/td-3019 | Taidoc Technology Corporation | DXN | Class II | |
| K091821 | Commander 111, Model Cd300-Cd399 | Cardiocom, LLC | DXN | Class II | |
| K091600 | Directvision Guide System | Percuvision, LLC | FGC | Class II | |
| K091439 | Head Fixation Arc and Table Base | Surgivision, Inc. | HBL | Class II | |
| K091423 | Profemur Hip System Modular Necks | Wrightmedicaltechnologyinc | KWA | Class III | |
| K091292 | Bd Vacutainer Rapid Serum Tube Plus Blood Collection Tube, Model 368771 | Becton, Dickinson & Company (BD) | JKA | Class II |