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 |
|---|---|---|---|---|---|
| K060975 | If True Sine Interferential Stimulator / Model Wl-2206A1 & Wi-2206A2 | Theratech, Inc. | LIH | Class II | |
| K060699 | Synvitro Cumulase (Hyaluronidase Medium) | Medicult A/S | MQL | Class II | |
| K060698 | Cement-It All Purpose, Model N97 | Pentron Clinical Technologies | EMA | Class II | |
| K060665 | Xpand Radiolucent Corpectomy Spacer | Globus Medical, Inc. | MQP | Class II | |
| K060656 | Sysmex Automated Hematology Analyzer Models Xs Series | Sysmex America, Inc. | GKZ | Class II | |
| K060386 | Nexa Carpo Metacarpal Implant | Nexa Orthopedics, Inc. | KYI | Class II | |
| K060358 | Profemur Tl Hip Stem | Wrightmedicaltechnologyinc | KWA | Class III | |
| K060340 | Oramagic Plus Oral Wound Rinse | MPM Medical | OLR | Unclassified | |
| K060331 | Sigma Alpha Vaporizer | Penlon, Ltd. | CAD | Class II | |
| K060284 | Cryocheck Clot Apcr | Precision BioLogic Inc. | GGW | Class II | |
| K060101 | Estech Aortic Easy Flow Cannula | Endoscopic Technologies, Inc. | DWF | Class II | |
| K053244 | Licox It2 Complete Brain Tunneling Probe Kit | Integra LifeSciences Corporation | GWM | Class II | |
| K052695 | Suretek Medical Reprocessed Arthroscopic Blades and Burs | Suretek Medical | NUJ | Class II | |
| K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | NUJ | Class II | |
| K052308 | Architect Anti-Tg Immunoassay Reagents, Calibrators, Controls and System Assay Cd-Rom | Fisher Diagnostics | JZO | Class II | |
| K051223 | Hipstar Femoral Stem | Stryker Orthopaedics | LZO | Class II | |
| K061126 | Accurex | Cybermed Inc. | LLZ | Class II | |
| K061054 | Axiom Aristos Fx Plus | Siemens Medical Solutions USA, Inc. | MQB | Class II | |
| K061030 | Bioblanket Surgical Mesh | DSM Biomedical, Inc. | FTM | Class II | |
| K060981 | Playtex Sport Plastic, Playtex Sport Plastic Multipack Tampons | Playtex Products, Inc. | HIL | Class II | |
| K060933 | Solace Post-Operative Pain Relief Infusion System | Apex Medical Technologies, Inc. | MEB | Class II | |
| K060925 | Acon Automatic Blood Pressure Monitor Kit, Model Ob11-111, W/ac Adapter, Model Ob11-112 | Acon Laboratories, Inc. | DXN | Class II | |
| K060155 | 15.5Fr Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips | Spire Biomedical, Inc. | MSD | Class II | |
| K053551 | Micromanipulation Media System, Lg Hyaluronidase and Lg Paraffin Oil | <Genx> Intl., Inc. | MQL | Class II | |
| K053298 | Alphasphere Orbital Implant | Hydron, Ltd. | HPZ | Class II | |
| K060786 | Synthetic (Yellow) Vinyl Patient Examination Glove-Powder Free | Ever Light Plastic Products Co., Ltd. | LYZ | Class I | |
| K060565 | Condylaform II Nfc | Ivoclar Vivadent, Inc. | ELM | Class II | |
| K060099 | S. Aureus Pna Fish | Advandx, Inc. | NXX | Class I | |
| K060094 | Arcadia Medical Silicone Wire Reinforced Endotracheal Tubes | Arcadia Medical Corporation | BTR | Class II | |
| K053639 | Given Diagnostic System | Given Imaging Ltd. | NEZ | Class II | |
| K060974 | Relient Navigation Device | Acclarent Inc | KAM | Class I | |
| K060957 | Modification to Blue Sky Bio Dental Implant System | Blue Sky Bio, LLC | DZE | Class II | |
| K060758 | Or Head Coil 1.5 T | Siemens Medical Solutions USA, Inc. | MOS | Class II | |
| K060560 | Ascension Pyrosphere Cmc/tmt | Ascension Orthopedics, Inc. | KWD | Class II | |
| K060519 | Introducer Assembly with Rotator Lock | Teleflex Medical | DYB | Class II | |
| K060383 | Glucose | Abbott Medical | CFR | Class II | |
| K060246 | Infrex | Johari Digital Healthcare, Ltd. | GZJ | Class II | |
| K060112 | Nodecrest Transcranical Doppler Ultrasound System | Nodecrest, LLC | IYN | Class II | |
| K060109 | Omi Retractable Safety Syringe | Vitalcare Group, Inc. | MEG | Class II | |
| K053453 | Hommed Central Station, Version 3.5 | Honeywell Hommed, LLC | DXN | Class II | |
| K053035 | Acro Biotech Llc Rapid Benzoylecgonine Urine Test; Catalog# Met001000 | ACRO BIOTECH Inc. | DIO | Class II | |
| K051760 | Navigant Workstation with Niobe Magnetic Navigation System, Model Nws05 | Stereotaxis Inc | DXX | Class II | |
| K061091 | Babybeat Cordless | The Newman Group, LLC | KNG | Class II | |
| K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan Xq-Models-9800010011/9800010005,9800010009/9800010004 | Esaote S.p.A. | LNH | Class II | |
| K060949 | Dp-6600 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYO | Class II | |
| K060930 | Insure II | Enterix, Inc. | KHE | Class II | |
| K060886 | Powdered Vinyl Patient Examination Gloves | Wei Fang Jiuzhou Gloves Co., Ltd. | LYZ | Class I | |
| K060884 | Powder-Free Vinyl Patient Examination Gloves | Wei Fang Jiuzhou Gloves Co., Ltd. | LYZ | Class I | |
| K060671 | Kvue Igrt Treatment Table Top, Rt-4551Kv, Kvue Inserts and Accessories, Various | Anholt Technologies Inc. | JAI | Class II | |
| K060553 | Rc Loop /Dual Orthocord Suture,rc Loop W/ethibond Suture,rc Loop W/panacryl Suture | DePuy Mitek, Inc. | JDR | Class II |