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 |
|---|---|---|---|---|---|
| K083398 | Cercom Cement | Denali R & D Corporation | EMA | Class II | |
| K083303 | Landlex, Model: 402X | Besteam Technology, Inc. | INI | Class II | |
| K083231 | Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, Bt | Panthera Production AB | IOR | Class I | |
| K083201 | Zmatch Block | Dentaim Co., Ltd. | EIH | Class II | |
| K083175 | Berichrom Heparin Uf Calibrator, Berichrom Heparin Uf Control 1, and Berichrom Heparin Uf Control 2 | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K083159 | Berichrom Heparin Lmw Calibrator, Berichrom Heparin Lmw Control 1, and Berichrom Heparin Lmw Control 2 | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K081838 | Gish Vision Blood Cardioplegia with Ha Coating | Gish Biomedical, Inc. | DTR | Class II | |
| K090061 | Airstrip Ob | AirStrip Technologies, Inc. | HGM | Class II | |
| K083835 | Attune Adjustable Flexible Annuloplasty Ring Model Afr | Abbott Medical | KRH | Class II | |
| K083647 | Valo, Model 5919 | Ultradent Products Inc. | EBZ | Class II | |
| K083489 | Jetstream Pathway Pc Atherectomy System, Model Ov10300 | Pathway Medical Technologies, Inc. | MCW | Class II | |
| K083470 | Carpentier- Edwards Physio II Annuloplasty, Model 5200 | Edwards Lifesciences LLC | KRH | Class II | |
| K083176 | Pasture, Models: F550, A520 | Pasture Pharma Pte Ltd | NZJ | Class II | |
| K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew | Arthrex GmbH | MAI | Class II | |
| K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set | Neochild, LLC | KNT | Class II | |
| K082668 | Bio-Screen | Addent, Inc. | NXV | Class II | |
| K082138 | Airgent, Model Ag7000010 | Perfaction, Inc. | KZE | Class II | |
| K081881 | Gish Tubing and Connectors with Ha Coating | Gish Biomedical, Inc. | DWF | Class II | |
| K081796 | Easyplus Mini R2n Self Monitoring Glucose Test System | Eps Bio Technology Corp. | NBW | Class II | |
| K081536 | Medisize Blue, Medisize Green, Medisize Red | Medisize BV | CAH | Class II | |
| K081279 | Pro-Tech Delivery System Electrodes, Model Tt-2000 | Transfer Technology | GXY | Class II | |
| K080134 | Compressible Limb and Circulation Therapy System, Model Whf-314 (Power-Q1000) | Wonjin Mulsan Co., Ltd. | IRP | Class II | |
| K090044 | Patlog, Patlog Patient Handling System, Patlog Toplog Table Top, Model(s) 1.0, 1.0, C | Oncolog Medical QA AB | IYE | Class II | |
| K083856 | Intracept Flexible Bi-Polar RF Probe and Curved Instrument Set, Models: Fg0018, Fg0026 | Relievant Medsystems | GEI | Class II | |
| K083826 | Laguna Polyaxial Pedicle Screw System | Allez Spine, LLC | MNH | Class II | |
| K083725 | Radpro Ion | Virtual Imaging, Inc. | OWB | Class II | |
| K083473 | Clear Bravo | Denali R & D Corporation | EBC | Class II | |
| K083264 | Rayautoplan 1.0 | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K083151 | Extremity Medical Suture Anchor | Extremity Medical, LLC | MBI | Class II | |
| K082353 | Mercury Spinal System | Spinal Elements, Inc | NKB | Class II | |
| K082212 | Syringe with Handi-Fil | Mallinckrodt Inc., Liebel-Flarsheim Business | DXT | Class II | |
| K081932 | Endeare Breast Pump | Hygeia Medical, Inc. | HGX | Class II | |
| K081797 | Image Storage System, Model Kss-400 | Konan Medical, Inc. | NFJ | Class II | |
| K081537 | Cfs Flexible | Comfort and Flexible Systems | EBI | Class II | |
| K083818 | Universal Electrodes | Neurometrix, Inc. | GXY | Class II | |
| K083795 | Cynosure Smartlipo Mpx Laser | Cynosure, LLC | GEX | Class II | |
| K083652 | Ibond Total Etch | Kulzer GmbH | KLE | Class II | |
| K083453 | Costorsol | Preservation Solutions Inc | KDN | Class II | |
| K082882 | A.v. Fistula Blunt Needle Set | JMS North America Corp. | FIE | Class II | |
| K082409 | Solar Laser Ablation System, Models: Lu-1083-25, Lf-1083, Pc-1000, Ic-1083, Lw-2000, Lg-2001, Lk-001, Pm-1083, Tf-1083 | Endophotonix, Inc. | GEX | Class II | |
| K081822 | Coulter 6C Cell Control, Models 628027 & A59925 | Siemens Healthcare Diagnostics Inc. | JPK | Class II | |
| K081811 | Care3 Plus | Nakanishi Inc. | EFB | Class I | |
| K080921 | Spiro-Master Pc-10 Spirometry System | Chest M.I., Inc. | BZG | Class II | |
| K083681 | Bioland Blood Pressure Monitor | Bioland Technology Ltd. | DXN | Class II | |
| K083578 | Noras Cpc Multifunctional Coil | NORAS MRI products GmbH | MOS | Class II | |
| K083553 | Naso-Laryngo-Pharyngoscope | Schoelly Imaging, Inc. | EOB | Class II | |
| K083517 | Intellivue Patient Monitor, Models Mp2, Mp5, Mp20, Mp30, Mp40, Mp50, Mo60, Mp7-, Mp80, and Mp90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | DSI | Class II | |
| K083387 | Modification to Kowa Nonmyd Alpha-Diii | Kowa Co., Ltd. | HKI | Class II | |
| K083194 | Virtuosaph (Tm) Endoscopic Vein Harvesting Disposable System, Model Mcvs550 | Terumo Cardiovascular Systems Corporation | GCJ | Class II | |
| K083099 | Easymax N Self Monitoring Blood Glucose System, Model: Eps08008 | Eps Bio Technology Corp. | NBW | Class II |