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 |
|---|---|---|---|---|---|
| K083086 | Echelon High Resolution Foot Coil (Mr-Hrf-150), Echelon Long Bone Coil (Mr-Lbc-150) | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K083029 | Model R605dasm Automatic X-Ray Collimator | Ralco S.r.l. | IZW | Class II | |
| K082972 | Kodak 9500 | Trophy | MUH | Class II | |
| K082950 | Starband | Orthomerica Products, Inc. | OAN | Class II | |
| K082913 | Bd Phoenix Automated Microbiology System-Doxycycline (Gp) 0.25-16 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K082893 | Prager Shell | Esi, Inc. | ITX | Class II | |
| K082607 | MRI-Plaque View, Version 1.1.2003 | Vpdiagnostics, Inc. | LLZ | Class II | |
| K082591 | Flexitime Bite | Kulzer GmbH | ELW | Class II | |
| K082049 | Liaison Anti-Hav Assay, Liaison Control Anti-Hav | Diasorin Inc. | LOL | Class II | |
| K082001 | Diazyme Liquid Stable Enzymatic Lithium Assay, Model Dz116b | Diazyme Laboratories, Inc. | JII | Class II | |
| K081990 | Lubricano Sterile Gel | Farco Pharma GmbH | FHX | Class II | |
| K081522 | Bio Nuclear Diagnostics (Endo)cervical Sampler for Gyn Cytology | Bio Nuclear Diagnostics, Inc. | HHT | Class II | |
| K081073 | Hdr Vision, Vision Hdr, Hd r/f, Uromat Hd r/f | Pausch Corp. | OWB | Class II | |
| K080595 | Cellavision Dm96 with the Body Fluid Application | Cellavision AB | JOY | Class II | |
| K080558 | Steritite Container System & Meditray Products | Case Medical, Inc. | FRG | Class II | |
| K072617 | Elecsys Rubella Igg Immunoassay | Roche Diagnostics GmbH | LFX | Class II | |
| K083454 | Nuovocath | U.S. Safety Syringes Co., Inc. | FOZ | Class II | |
| K083343 | Headway 17 Microcatheter | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K083109 | Suinsa Diagnostic X-Ray System | Suinsa | KPR | Class II | |
| K082962 | Tivamed Cooled RF System, Model 78001 | Tivamed, Inc. | GEI | Class II | |
| K082935 | Vision Wire Coronary Guidewire | BIOTRONIK AG | DQX | Class II | |
| K082854 | Nanocorss .014 Otw Pta Dilatation Catheter | Medtronic, Inc. | DQY | Class II | |
| K082749 | Omni-Tight | Basic Dental Implant Systems, Inc. | DZE | Class II | |
| K082670 | Modification to: Attain Prevail 6228Cth80 Steerable Catheter Set | Medtronic, Inc. | DQY | Class II | |
| K082585 | Depuy Asphere M-Spec Head | Depuy Orthopaedics Inc. | KWA | Class III | |
| K082387 | Apogee and Perigee Systems with Intepro Lite and Intexen Lp, Part of the Ams; Pelvic Floor Repair System | American Medical Systems, Inc. | OTP | Class III | |
| K082169 | Pro Glucose Test Strip | Taidoc Technology Corporation | NBW | Class II | |
| K081861 | Holter Lx Analysis | North East Monitoring, Inc. | MNR | Class II | |
| K081848 | Lipose Fat Transfer System | Lipose Corp. | MUU | Class II | |
| K081697 | The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006 | Access Scientific, Inc. | DYB | Class II | |
| K081635 | Integra Meshed Bilayer Wound Matrix | Integra LifeSciences Corporation | KGN | Unclassified | |
| K080903 | Zoll E Series with Intibation Assist Option | ZOLL Medical Corporation | MKJ | Class III | |
| K080485 | Aspartate Amino Transferase (Ast/sgot) Test System, Asat (Got) Fs | Diasys Diagnostics Systems GmbH | CIT | Class II | |
| K072562 | Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | HRS | Class II | |
| K071849 | Allofuse Gel and Putty | Allosource | MQV | Class II | |
| K083230 | Mercury Spinal System | Spinal Elements, Inc | NKB | Class II | |
| K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices | Peak Surgical, Inc. | GEI | Class II | |
| K082566 | Mark 5 Nuvo Lite Ocsi and Std | Nidek Medical Products Inc | CAW | Class II | |
| K082423 | No!no! Skin | Radiancy (Israel), Ltd. | GEX | Class II | |
| K082408 | Ledex, Model: Wl-070 | Dentmate Technology Co., Ltd. | EBZ | Class II | |
| K082380 | Vicardio 12B | Energy-Lab Technologies GmbH | DPS | Class II | |
| K082225 | 15W Ceralas D 1470Nm Diode Laser, Model D1470 | Biolitec, Inc. | GEX | Class II | |
| K081739 | 2-Port Through-the-Peg (Ttp) Jejunostomy Tube Kit | Boston Scientific Corporation | KNT | Class II | |
| K081592 | Powder Free Nitrile (Blue and White) Examination Gloves | Quality Gallant Sdn. Bhd. | LZA | Class I | |
| K082546 | Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips Adult Soft Tip Sensor(u403s-91) | Unimed Medical Supplies Inc | DQA | Class II | |
| K082539 | Masterscope, Masterscope ECG, Masterscope CT | Cardinal Health Germany 234 GmbH | BTY | Class II | |
| K081786 | Ziocera & Convertible System | OSSTEM Implant Co., Ltd. | NHA | Class II | |
| K082535 | Covidien Sports Surgery as Meniscal Repair Device | Surgical Devices, A Global Business Unit Covidien | GAT | Class II | |
| K082456 | Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600 | Verathon Incorporated | IYO | Class II | |
| K082208 | Doctors Choice Slow Healing Bandage with Spray on Remover | Scivolutions, Inc. | NAC | Class I |