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 |
|---|---|---|---|---|---|
| K993403 | Remed Male Tutti Frutti Condom (Strawberry) Preventor, Lucky Boy, Summit | Remed Pharma | HIS | Class II | |
| K993389 | Remed Male Tutti Frutti Condom (Banana), Preventor, Lucky Boy, Summit | Remed Pharma | HIS | Class II | |
| K002415 | Powerdrive 350 Option | Philips North America LLC | LNH | Class II | |
| K002279 | Ml Eye Spear, Model Ml 27 Es | Med-logics Inc | HOZ | Class II | |
| K002230 | Cambridge Heart Micro-V Alternans Sensor, Model 20327-002 | Cambridge Heart, Inc. | DRX | Class II | |
| K002209 | Ge Marquette ECG Analysis Program | General Electric Medical Systems Information Techn | MHX | Class II | |
| K002194 | Treatvision | Varian Medical Systems, Inc. | LHN | Class II | |
| K001908 | Kontur 55 Soft Lens | Kontur Kontact Lens Co., Inc. | LPL | Class II | |
| K001832 | Paradigm Sof-Set Ultimate Qr, Models 317 and 318 | Minimed, Inc. | FPA | Class II | |
| K001829 | Minimed Paradigm Insulin Pump, Model 511 | Minimed, Inc. | FRN | Class II | |
| K001828 | Paradigm 1.5Ml Reservoir, Model 326 | Minimed, Inc. | FRN | Class II | |
| K001827 | Paradigm Sof-Set Micro Qr, Models 324 and 325 | Minimed, Inc. | FPA | Class II | |
| K001773 | Orthone | Oni, Inc. | LNH | Class II | |
| K001653 | Xia Spine System Sacral Block Assembly | Howmedica Osteonics Corp | KWP | Class II | |
| K001615 | Hunter Scientific Injection Pipettes | Hunter Scientific Ltd | MQH | Class II | |
| K001589 | Candela Dynamic Cooling Device | Candela Corporation | GEX | Class II | |
| K001325 | Flo Assistant, Model 4-250-00 | Northgate Technologies Inc. | LJH | Class II | |
| K000209 | Dose 1 | Scanditronix Wellhofer North America | IYE | Class II | |
| K993042 | Medivators 5 Minute High-Level Disinfectant | Medivators Inc | MED | Class II | |
| K002397 | M2430 Diagnostic Ultrasound System with the 21420 Transducer | Agilent Technologies, Inc. | IYN | Class II | |
| K002347 | Cooltouch II | New Star Lasers, Inc. | GEX | Class II | |
| K002314 | Latex Patient Examination Gloves Powdered with Protein Content Labeling Claim; 100 Microgram or Less of Total Water Extr | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | |
| K002281 | Stelkast Proven Knee System | Globus Medical, Inc. | JWH | Class II | |
| K002086 | Primaflow | Dmg USA, Inc. | EBF | Class II | |
| K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | FED | Class II | |
| K002002 | Surefit Dispersive Electrode | Conmedcorp | GEI | Class II | |
| K001858 | Operating Room Towel, Sterile, Colors Blue or White | China Nantong Guangda Textile Co., Ltd. | KKX | Class II | |
| K001793 | Synthes Scalloped Distal Tibia Plate | Synthes (USA) Products LLC | LXT | Class II | |
| K001588 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Arthrocare System 20 | ArthroCare Corporation | GXI | Class II | |
| K001580 | Gross Femoral Component | Zimmer GmbH | MEH | Class II | |
| K000605 | Stackhouse Lens Hood, Model Sa-700/F | Stackhouse, Inc. | FYA | Class II | |
| K993698 | Slimcath-Dx Models, 3Suxxxx, 3Sbxxxx, and Fcxxxx | Mogul Enterprises | DRF | Class II | |
| K002141 | Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series Press-Fit | Exactech, Inc. | LWJ | Class II | |
| K002041 | Willi Geller Creation & Av Porcelain | Jensen Industries, Inc. | EIH | Class II | |
| K002008 | Surgical Dynamics Spinal Retractor | United States Surgical, A Division of Tyco Healthc | HRX | Class II | |
| K001969 | Gt2 Fusion Guide Wire, Model Ntlhlj180,ntlhls180, Ntlhlj300, Ntlhls300 | Medtronic, Inc. | DQY | Class II | |
| K001823 | Linkmax | GC America Inc. | EMA | Class II | |
| K001706 | Wmt Modular Shoulder System | Wrightmedicaltechnologyinc | KWS | Class II | |
| K001562 | Neuro Scan Medical Systems A4000 | Neuro Scan Labs | IKN | Class II | |
| K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) | Asahi Kasei Medical MT Corp. Oita Works | KDI | Class II | |
| K001106 | Mastersite Needleless Luer Activated IV Connector, Model Ms 1000 | Creative Plastic Technology | FPA | Class II | |
| DEN000007 | Quanta Lite Asca (S. Cerevisiae) Igg Elisa | Inova Diagnostics, Inc. | NBT | Class II | |
| K993934 | V Quick Patch | Vq Corp. | DRX | Class II | |
| K002419 | Surgical Drapes | Allegiance Healthcare Coporation | KKX | Class II | |
| K002220 | Nitrile Exam Glove, Pre-Powdered, Color Blue | Shanghai Champion Plastic Products Co., Ltd. | LZA | Class I | |
| K002218 | Nitrile Exam Glove, Powder-Free, Color Blue | Shanghai Champion Plastic Products Co., Ltd. | LZA | Class I | |
| K000888 | Sansibar CPAP System | Prym Medical, Ltd. | BZD | Class II | |
| K000685 | Charter Medical Neonatal Syringe Set | Charter Medical, LLC | BRZ | Class II | |
| K994406 | Instant-View Methamphetamine Urine Dip Strip Test | Alfa Scientific Designs, Inc. | DJC | Class II | |
| K994403 | Instant-View Cocaine (Benzylecgonine) Urine Dip Strip Test | Alfa Scientific Designs, Inc. | DIO | Class II |