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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K181189 | ATLANTIS Conus Structure | Dentsply Sirona Inc | NHA | Class II | |
| K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K181062 | Ultra Facial Toning System | Micro Current Technology, Inc. | NFO | Class II | |
| K181015 | Braun BFH175 Infrared Forehead Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | |
| K181014 | Tritanium PL Cage | Howmedica Osteonics Corp | MAX | Class II | |
| K180977 | KARL STORZ New Generation Trocars | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K180784 | ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K180027 | ACCUSYTE 3D Fiducial Marker | Radiation Products, LLC | IYE | Class II | |
| K173829 | NeoLSD MSMS kit | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | PQW | Class II | |
| K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters | Boston Scientific Corporation | DQO | Class II | |
| K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics Inc. | NKB | Class II | |
| K173327 | DIP/U.S. Urine Analysis Test System | Healthy.io Ltd. | JIL | Class II | |
| K172653 | Power Infuser | ZOLL Medical Corporation | FRN | Class II | |
| K172389 | ePTFE-Coated Auricular Implant | Implantech Associates Inc | FZD | Class II | |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | PENTAX of America, Inc. | EOB | Class II | |
| K170820 | Capnograph and Oximeter | CMI Health, Inc. | CCK | Class II | |
| K181375 | Apex Femoral Nailing System | Orthoxel | HSB | Class II | |
| K181030 | Rubicon Lumbar Interbody Fusion System | Rubicon Spine, LLC | MAX | Class II | |
| K180915 | Sonicision Reusable Sterilization Tray | Medtronic, Inc. | KCT | Class II | |
| K180348 | Field Orthopaedics Micro Screw System | Field Orthopaedics | HWC | Class II | |
| K180269 | Cadwell Apollo System | Cadwell Industries Inc | GWQ | Class II | |
| K173968 | Straumann Variobase for Bridge/Bar Cylindrical | Straumann USA, LLC | NHA | Class II | |
| K173797 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | CHL | Class II | |
| K173654 | Ureteral Dilator Sets, Ureteral Dilators | Cook Incorporated | EZN | Class II | |
| K171272 | Cook-Swartz Doppler Flow Probe | Cook Incorporated | ITX | Class II | |
| K181600 | PathLoc-SI Joint Fusion System | L&K Biomed Co.,Ltd. | OUR | Class II | |
| K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | |
| K181115 | CxHA PEEK Cervical IBF System | Innovasis, Inc | ODP | Class II | |
| K181019 | Diode Laser System | Guangzhou Huafei Tongda Technology Co., Ltd. | GEX | Class II | |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | Welch Allyn Inc | NFJ | Class II | |
| K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics Inc. | PMT | Class II | |
| K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | DXJ | Class II | |
| K180526 | Eidon Fa | Centervue | MYC | Class II | |
| K180151 | MC3 Jugular Dual Lumen Catheter | Mc3 Incorporated | PZS | Class II | |
| K181029 | Solana Bordetella Complete Assay | Ortho-Clinical Diagnostics, Inc. | OZZ | Class II | |
| K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | KLW | Class II | |
| K181565 | Aquarius 8600 Digital Radiography Sensor | Biokinemetrics Inc. | MQB | Class II | |
| K181556 | EliA M2 Immunoassay | Phadia AB | DBM | Class II | |
| K181134 | G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray | Sunstar Americas, Inc. | LFD | Unclassified | |
| K181063 | Kestrel™ Buttress Plate System | Innovasis, Inc | KWQ | Class II | |
| K180673 | Normandy VBR System | Zavation Medical Products, LLC | PLR | Class II | |
| K180655 | Viking Lumbar Polyaxial Screw System | Presidio Surgical, Inc. | NKB | Class II | |
| K180654 | PINXEL-RF system | Rohrer Aesthetics, Inc. | GEI | Class II | |
| K180011 | Pulmonx Chartis Tablet Console | PULMONX, Corp. | BZG | Class II | |
| K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics Inc. | PDJ | Class II | |
| K173556 | Injection Screw | Biedermann Medtech, Inc. | HWC | Class II | |
| K173340 | Yikang Latex Foley Catheter | Jiangxi Yikang Medical Instrument Group Co., Ltd. | EZL | Class II | |
| K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | GMAX Industries, Inc. | FYA | Class II | |
| K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 | Dongguan Prestige Sporting Goods Co., Ltd. | INI | Class II | |
| K171880 | IRRAflow CNS System | Irras, Inc. | JXG | Class II |