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 |
|---|---|---|---|---|---|
| K061457 | Ucp Rapid Drug Screening Tricyclic Antidepressant, Propoxyphene Tests | Ucp Biosciences, Inc. | LFG | Class II | |
| K061433 | Vanguard Anatomic Patella Groove (Apg) / Vanguard V Groove | Biomet Manufacturing Corp | MBH | Class II | |
| K060727 | Vectorvision Hip | Brainlab, Inc. | HAW | Class II | |
| K053555 | Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L | Guilin Woodpecker Medical Instrument Co., Ltd | ELC | Class II | |
| K062310 | Reflex Hybrid Acp System | Howmedica Osteonics Corp | KWQ | Class II | |
| K062247 | Hd11 Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K062168 | Contrast Delivery System - Dual Shot Alpha | Nemoto Kyorindo Co., Ltd. | DXT | Class II | |
| K062116 | Delta Cta Reverse Shoulder System Humeral Heads | Depuy Orthopaedics Inc. | PHX | Class II | |
| K062107 | Securview Dx Diagnostic Workstation, Models Sv-0001, Sv-0002 and Sv-0003 | Hologic, Inc. | LLZ | Class II | |
| K062084 | 7F Acumen Coronary Sinus Visualization System, Model Csvs-7-67 | Acumen Medical, Inc. | DQY | Class II | |
| K061950 | Hhf1 Echelon Multi-Purpose Coil | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K061926 | Coronis 2Mp and Mdcg 2121 - Cb | Barco N.V. | LLZ | Class II | |
| K061918 | Foley Catheters with Temperature Probe | GE Healthcare | EYC | Class II | |
| K061903 | Relieva Sinus Balloon Catheter | Acclarent Inc | LRC | Class I | |
| K061891 | Synex II | Synthes Spine Co.Lp | MQP | Class II | |
| K061873 | Vert-X | Direx Systems Corp. | OXO | Class II | |
| K061869 | Bd Phoenix Automated Microbiology System-Piperacillin-Tazobactam (Gp) 1/4-128/4 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses | Grace Medical, Inc. | ETB | Class II | |
| K061736 | Comfort Flo Humidification System and Nasal Cannula | Teleflex Medical | BTT | Class II | |
| K061699 | Excia | Aesculap Inc | LWJ | Class II | |
| K061560 | Sonomark | Medical Products Manufacturing, Inc. | ITX | Class II | |
| K061401 | Interplate Vbr System | RSB Spine LLC. | MQP | Class II | |
| K061279 | Ld-578 Fully Automatic Digital Blood Pressure Monitor | Little Doctor (Shanghai) Electronic | DXN | Class II | |
| K061223 | Advance Total Knee System | Wrightmedicaltechnologyinc | MBH | Class II | |
| K060657 | Isleep by Breas, Models Isleep 10, Isleep 20. | Breas Medical AB | BZD | Class II | |
| K062248 | Azuryt Model Ctl 1401, CO2 Surgical Laser System | North American Clinical Lasers, Ltd. | GEX | Class II | |
| K062224 | Respcare Hybrid Av Mask | Respcare, Inc. | BZD | Class II | |
| K062221 | Cxdi-40Ec | Canon, Inc. | MQB | Class II | |
| K062019 | Respcare Hybrid Ne Face Mask, Model Tbd,; Disposable, Model Tbd | Innomed Technologies, Inc./Respcare, Inc. | CBK | Class II | |
| K061980 | Siemens Acuson X500 Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K061808 | Darco Locking Bone Plate System | Darco International Corporation | HRS | Class II | |
| K061721 | Pedi-Spider Strap | Emergency Products & Research, Inc. | NZD | Class I | |
| K061595 | Xaminer | Imaging Dynamics Company, Ltd. | KPR | Class II | |
| K061448 | Bonart Art-P3ii & P4 Piezo Electric Ultrasonic Scaler Units with Accessories | Bonart Co. Ltd. | ELC | Class II | |
| K061371 | Sydney Ivf Sperm Cryopreservation Buffer | Cook Incorporated | MQL | Class II | |
| K061354 | Microselectron V3, Model 106.990 | Nucletron BV | JAQ | Class II | |
| K060652 | Tigris Dts Gen-Probe Aptima Combo 2 Assay | Hologic, Inc. | LSL | Class II | |
| K060559 | Zoll R Series Defibrillator | ZOLL Medical Corporation | MKJ | Class III | |
| K062218 | Jan Mao Wheelchair, Models Jmc612-Fl318epp and Jmc612-Fl418epp | Jan Mao Industries Co., Ltd. | IOR | Class I | |
| K062195 | Modification to One Touch Ultra Blood Glucose Monitoring System | Lifescan, Inc. | NBW | Class II | |
| K062152 | Creatinine Kinase Mb Isoenzyme Verifier, Model Dc27 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K062132 | Avs Pl Peek Spacer System | Howmedica Osteonics Corp | MQP | Class II | |
| K062110 | Vertebron Scp Cervical Plate System | Vertebron, Inc. | KWQ | Class II | |
| K062041 | Model 3875 1 X 8 Sc Test Stimulation Lead | Medtronic, Inc. | GZB | Class II | |
| K062007 | Dms 300-7 | Diagnostic Monitoring Software | DSH | Class II | |
| K061581 | Excel High Speed Dental Handpiece | Orthosource, Inc. | EFA | Class I | |
| K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 Mm X 6Mm,8mm, Model 454-91001,454-91002 and 1.2/1.5Mm X 6,8,10Mm, M | Ace Surgical Supply Co., Inc. | OAT | Class II | |
| K060738 | Tdm N-Acetylprocainamide | Roche Diagnostics GmbH | LAN | Class II | |
| K060372 | Intralase Fs Laser, Intralase Fs30 Laser, Models 1, 2, 3 | Intra Lase Corp. | GEX | Class II | |
| K060325 | Abx Pentra Bilirubin, Direct Cp, Abx Pentra Bilirubin, Total Cp, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P | Horiba Abx | CIG | Class II |