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 |
|---|---|---|---|---|---|
| K082606 | Commissioning Data Management System (Cdms) | D3 Radiation Planning | MUJ | Class II | |
| K082463 | Progenix | Medtronic Sofamor Danek | NUN | Class II | |
| K082457 | Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use) | Ansell Healthcare Products LLC | LZA | Class I | |
| K082412 | Venous Bubble Trap, Model Vbt 160; Venous Bubble Trap with Bioline Coating, Model Be-Vbt 160, Beq-Vbt 160 | Mapquet Cardiopulmonary AG | DTP | Class II | |
| K082335 | Synthes Matrixmandible Plate and Screw System | Synthes (USA) Products LLC | JEY | Class II | |
| K082310 | Hollywood, Pacifica, Redondo, Ventura | Seaspine, Inc. | MAX | Class II | |
| K082013 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | DPS | Class II | |
| K081687 | Liaison Hsv-2 Type Specific Igg Assay, Control Hsv-2 Igg | Diasorin Inc. | MYF | Class II | |
| K080976 | Nexus i.v. Fluid Transfer Device | Nexus Medical, LLC | LHI | Class II | |
| K080771 | Top Neuropole Needle, Model Sh, Bl, Sc, Tc | Top Corp. | GXI | Class II | |
| K083160 | 1.5T Atlas Speeder Head-Neck Coil | Quality Electrodynamics | MOS | Class II | |
| K083148 | Telectrode Wet Gel ECG Electrode | Bio Protech, Inc. | DRX | Class II | |
| K083141 | Simpact Endosseous Dental Implant System | Simpact, LLC | NHA | Class II | |
| K082974 | Mystique Mb Ceramic Brackets | Dentsply Interntional | NJM | Class II | |
| K082688 | Pro Hmpv+ Assay | Prodesse, Inc. | OEM | Class II | |
| K082642 | Oncentra Rt Viewer 1.0 | Nucletron BV | MUJ | Class II | |
| K082627 | Minxray, Model Cmdr-1S and Cmdr-1S-Mil | Minxray Inc | IZL | Class II | |
| K082619 | Sils Port, Models Silspt5, Silspt12 | Covidien Lp, Formerly Registered AS United States | GCJ | Class II | |
| K082512 | Intelligent Dosing System for Insulin-My Insulin Doser | Dimensional Dosing Systems, Inc. | NDC | Class II | |
| K082475 | Reveal Xt Insertable Cardiac Monitor, Model 9529, Revel Dx Insertable Cardiac Monitor, Model 9528 | Medtronic, Inc. | DSI | Class II | |
| K082454 | Micromyst Applicator, Model 20-5000 | Medtronic, Inc. | FMF | Class II | |
| K082427 | Syngo Mr B17 | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K082369 | Cadence, Cadence Dual, Cadence II Fetal Monitor | Edan Instruments, Inc. | HGM | Class II | |
| K082282 | Healix Ti Anchor | DePuy Mitek, Inc. | HWC | Class II | |
| K082266 | Digital Clinical Thermometer Model V9xx | Amperor-Electronic(Sz) Co., Ltd. | FLL | Class II | |
| K082243 | Precision Rxi Analog and Digital X-Ray Systems | General Medical Merate S.p.A. | OWB | Class II | |
| K082113 | Nox T3, Noxturnal (Pc Application) | Nox Medical | MNR | Class II | |
| K082072 | Synthes (USA) 3.5Mm Lcp Hook Plate | Synthes (USA) Products LLC | HRS | Class II | |
| K082066 | Tao Brush I.u.m.c. Endometrial Sampler | Cook Incorporated | HFE | Class II | |
| K082056 | Anorectal Manometry Software Option Arm-1 | Life-Tech, Inc. | FFX | Class II | |
| K081806 | Idi Implant System | Idi Biomedical, LLC | DZE | Class II | |
| K081725 | Enteral Pump Set, Model 20-1010 | Viasys Medsystems | KNT | Class II | |
| K081570 | Dpl Therapy System | LED Technologies, Inc. | ILY | Class II | |
| K081420 | Vanishpoint i.v. Catheter | Retractable Technologies, Inc. | FOZ | Class II | |
| K081128 | Molar Implant | Nobel Biocare AB | DZE | Class II | |
| K081062 | Airsonnett Airshower Air 3 | Airsonett AB | FRF | Class II | |
| K081011 | Arex Scru 2 Headless Compression Screws, Models: P2p10, P2p15, P2p20, P2p25, P2p30, P2p35, P2p40, P2p45 | Arex USA | HWC | Class II | |
| K083083 | Agilis Nxt Steerable Introducer | Abbott Medical | DYB | Class II | |
| K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute | DSM Biomedical, Inc. | MQV | Class II | |
| K082987 | Hrk-63-16 Knee Array Coil, Hrk-127-16 Knee Array Coil | Invivo Corporation | MOS | Class II | |
| K082706 | Infinitt Cardiology Pacs | Infinitt Co., Ltd. | LLZ | Class II | |
| K082261 | Dxrad Models Dx800 or Dx808 Digital Diagnostic Radiographic Systems | Dxrad Solutions, Ltd. | KPR | Class II | |
| K081979 | Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft Substitute | Apatech Ltd. | MQV | Class II | |
| K081773 | Osv II | Integra Neurosciences Implants S.A. | JXG | Class II | |
| K081456 | Olympus Chf Type V | Olympus Medical Systems Corp. | FBN | Class II | |
| K081088 | Myray Skyview | Cefla S.C. | MUH | Class II | |
| K080613 | Clear-Vu System, Models: Cvl-01-1000, Cvl-01-1030, Cvl-01-1045 | Minimally Invasive Devices, LLC | OCT | Class II | |
| K082980 | Arthrocare Arthrowands | ArthroCare Corporation | GEI | Class II | |
| K082720 | Tracheal Intubation Fibervideoscope, Models Lf-Y0004 and Lf-Y0005 | Olympus Medical Systems Corp. | EOQ | Class II | |
| K082320 | Darco Small Screw | Wrightmedicaltechnologyinc | HWC | Class II |