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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K240311 | JETT Medical II | Compex, Spol, s.r.o. | GEI | Class II | |
| K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | QHE | Class II | |
| K243929 | Oligio X | WONTECH Co., Ltd. | GEI | Class II | |
| K243303 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | OWB | Class II | |
| K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | GEH | Class II | |
| K241444 | Biliary Pancreaticobiliary Scope System | Shenzhen Hugemed Medical Technical Development Co., Ltd | FBN | Class II | |
| K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) | Hathor Professional Skincare Ltd. | NUC | Class II | |
| K241910 | Neonav ECG Tip Location System | Navi Medical Technologies Pty Ltd | LJS | Class II | |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) | Access Vascular, Inc | LJS | Class II | |
| K243935 | Aptima CMV Quant Assay | Hologic, Inc. | PAB | Class II | |
| K243892 | Affera Integrated Mapping System | Medtronic, Inc. | DQK | Class II | |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Medtronic Sofamor Danek | MQV | Class II | |
| K243606 | Babyroo TN300 | Draeger Medical Systems, Inc. | FMT | Class II | |
| K243605 | Aurora | GE Medical Systems Israel, Functional Imaging | KPS | Class II | |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical Inc. | KNS | Class II | |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | Philips Medizin Systeme Boblingen GmbH | DSA | Class II | |
| K243502 | Evis Eus Endoscopic Ultrasound Center Olympus EU-Me3 (Olympus EU-Me3) | Olympus Medical Systems Corp. | IYN | Class II | |
| K243315 | ProGrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | FTL | Class II | |
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | HGP | Class II | |
| K243249 | TriALTIS™ Spine System | Medos International SARL | NKB | Class II | |
| K243218 | TBS iNsight (V4) | Medimaps Group SA | KGI | Class II | |
| K243067 | The ETHICON™ Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | GEI | Class II | |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating LLC | JOJ | Class II | |
| K242825 | Prenuvo Body Composition | PRENUVO Inc. | LNH | Class II | |
| K242765 | Electronic Apex Locator (Alpha Apex I) | Shenzhen Superline Technology Co.,Ltd | LQY | Unclassified | |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) | Medtronic, Inc. | LDF | Class II | |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | KRD | Class II | |
| K242374 | ULSPIRA TS™ Nitric Oxide Therapy System | Airgas Therapeutics LLC | MRN | Class II | |
| K242336 | hygh-tec Drainage II | Amb Medtec | KNT | Class II | |
| K242171 | TechCare Trauma | Milvue | QBS | Class II | |
| K242064 | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | NHA | Class II | |
| K242051 | VersaD Delivery Catheter | Unity Medical, Inc. | QJP | Class II | |
| K241949 | Digital Color Doppler Ultrasound System (P60 Series) | Sonoscape Medical Corp. | IYN | Class II | |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology Inc. | HAW | Class II | |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | ETA | Class II | |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | |
| K240217 | cobas® liat CT/NG nucleic acid test | Roche Molecular Systems Inc | QEP | Class II | |
| DEN230051 | Myocene | Myocene | SDX | Class II | |
| K244048 | Medi Lift Mask | YA-Man Ltd. | NFO | Class II | |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | BioFire Diagnostics, LLC | PCH | Class II | |
| K243848 | Cala kIQ | Cala Health, Inc. | QBC | Class II | |
| K243289 | Addnox (Bpspm1) | NU Eyne Co., Ltd. | QGL | Class II | |
| K243256 | WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co., Ltd. | SCA | Class II | |
| K242834 | System 9 Sterile Battery Container | Stryker Corp. | KCT | Class II | |
| K242715 | Pearl Clear Aligner | Pearl Digital, Inc. | NXC | Class II | |
| K242522 | Second Opinion CC | Pearl, Inc. | MYN | Class II | |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research & Development Corp. | FRN | Class II | |
| K241217 | CloudHRV™ System (100-01-001) | Inmedix, Inc. | DPS | Class II |