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 |
|---|---|---|---|---|---|
| K010069 | Durabond Non-Precious Ceramic Alloy | Matech, Inc. | EJH | Class II | |
| K004032 | Perfecta and Extend | Wrightmedicaltechnologyinc | LPH | Class II | |
| K004019 | Ana Eia Diagnostic Test Kit | The Binding Site | LJM | Class II | |
| K003977 | Disetronic Rapid Subcutaneous Infusion Set and Disteronic Rapid D Subcutaneous Infusion Set | Disetronic Medical Systems | FPA | Class II | |
| K003922 | Nitrile Examination Gloves (Powered) | Guthrie Medicare Products (Melaka) Sdn Bhd | LZA | Class I | |
| K003915 | Accufuser; Accufuser Plus | Help Technologies | MEB | Class II | |
| K003650 | Permlastic 3 | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K003607 | Onyx-Rad Telemedicine Pacs | Viztek, LLC | LLZ | Class II | |
| K003599 | Smith & Nephew Suture Anchor | Smith & Nephew, Inc. | HWC | Class II | |
| K003572 | Dyonics Control RF System | Smith & Nephew, Inc. | HRX | Class II | |
| K003549 | Codman Craniosorb Absorbable Fixation System Purple Rivets | Cerenovus, Inc. | JEY | Class II | |
| K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | FTL | Class II | |
| K002596 | Gebauer's Fluro Ethyl, Model 0386-0002-09 | Gebauer Co | MLY | Unclassified | |
| K002406 | Mitek 2Gii Meniscal Repair System | Mitek Products | MAI | Class II | |
| K001147 | Enhanced Polyethylene Knee Prostheses | Howmedica Osteonics Corp | JWH | Class II | |
| K010343 | Bmr Dental Implant System, Model 3.3Xx, Either Ha or Tps Coated, 3.308, 3.310,3.312, 3.314 3.316 | Buck Medical Research | DZE | Class II | |
| K010342 | M2376a Devicelink System, Model M2376a | Agilent Technologies, Inc. | MWI | Class II | |
| K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,Model K01a, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02a | Medtronic, Inc. | HRX | Class II | |
| K010237 | Elecsys Hcg+b Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K010212 | Offset Tibial Tray | Zimmer GmbH | MBV | Class II | |
| K010187 | Kimax, Model 1024 | Medical Metrics, Inc. | JAA | Class II | |
| K010138 | Profile II Er | MEDTOX Diagnostics, Inc. | LDJ | Class II | |
| K010075 | Teknique | Hoveround Corp. | ITI | Class II | |
| K010030 | Liquispx Hdl/ldl Liquid Cholesterol Calibrator | Synergent Biochem Inc.-Clinical Controls Div. | JIX | Class II | |
| K010012 | Lc Provifill | S & C Polymer GmbH | EBG | Class II | |
| K004002 | Immulite Ck-Mb, Model Lkmb1 (100 Tests), Lkmb5 (500 Tests); Immulite 2000 Ck-Mb, Model L2kmb2 (200 Tests), L2kmb6 (600) | Siemens Healthcare Diagnostics Inc. | JHX | Class II | |
| K003936 | Panoramic Scan, Panoramic View, Widas, Wide Area Scanning | TOMTEC Imaging Systems GmbH | IYO | Class II | |
| K003795 | Biolucent Mammography Cushion | Biolucent, Inc. | IZH | Class II | |
| K003782 | Constellation Catheter, Model 8031 | Boston Scientific Corporation | MTD | Class II | |
| K003718 | Titanium Cement Restrictor (Tcr) | Medtronic Sofamor Danek | JDK | Class II | |
| K003695 | Microscope-Stainless Steel/fiber Optic: .5-2.6Mm Model Mmd 4500 Series and 2.7-5.0Mm Model Mmd-4700 Series | Micro Medical Devices, Inc. | HRX | Class II | |
| K003667 | Reveal Plus Insertable Loop Recorder | Medtronic, Inc. | MXC | Class II | |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110 | Wallac Oy | CGZ | Class II | |
| K003591 | Tenscare, Model TENS Xl-2 | Tenscare Ltd. | GZJ | Class II | |
| K003566 | Cofield Eccentric and Lateral Offset Humeral Heads | Smith & Nephew, Inc. | KWS | Class II | |
| K003419 | Rcrp Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | DCN | Class II | |
| K002210 | Syntra Dialyzer, Model Syntra 120, 160 | Baxter Healthcare Corporation | KDI | Class II | |
| K001329 | Intravascular IV Set, IV Set with Burette, Extension Set | Lifemed of California | FPA | Class II | |
| K010340 | Modulith Lithotripsy, Model Slk for the Fragmentation of Urinary and Upper Ureteral Calculi | Karl Storz Lithotripsy-America, Inc. | LNS | Class II | |
| K010169 | Bard Utraverse Small Vessel Pta Balloon Dilatation Catheter | C.R. Bard Inc | DQY | Class II | |
| K010137 | Orbiter II Cci/spect Orbiter II Cci/spect | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K010004 | Flowrider Flow Directed Micro Catheter, Model 105-5065 | Medtronic, Inc. | KRA | Class II | |
| K003853 | Infinion 1.5T Mr Imaging System, Model MRI 100 | Philips North America LLC | LNH | Class II | |
| K003833 | Specialty 55 & Multifocal (Methafilcon a) Soft (Hydrophilic Contact Lenses for Daily Wear | Clearlab Pte, Ltd. | LPL | Class II | |
| K003638 | Mojave Cataract Extraction System | Allergan | HQC | Class II | |
| K003522 | Salute | Onux Medical, Inc. | GDW | Class II | |
| K002583 | Tuna (Trans Urethra Needle) Office System | Vidamed, Inc. | KNS | Class II | |
| K001585 | Biocurve Soft (Methafilcon a) Spherical and Toric Soft Contact Lens for Daily Wear (Clear & Blue Visibility Tint, Lathe | American Biocurve, Inc. | LPL | Class II | |
| K010304 | Mxr-2000 Mobile X-Ray Unit | Irom Imaging, Inc. | IZL | Class II | |
| K010189 | Vortex Access System | Boston Scientific Corporation | LJT | Class II |