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 |
|---|---|---|---|---|---|
| K234077 | SPIRA® Anterior Lumbar Spacers | Camber Spine Technologies | MAX | Class II | |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | QIH | Class II | |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | MSX | Class II | |
| K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) | Megadyne Medical Products, Inc | GEI | Class II | |
| K233557 | HemoCare Hemodialysis System | Deka Research & Development Corp. | KDI | Class II | |
| K233457 | Rus | Hutom Inc. | QIH | Class II | |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Peters Surgical | GAM | Class II | |
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | Terragene LLC | QVB | Class II | |
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | ACell, Inc | KGN | Unclassified | |
| K241711 | Oscar Peripheral Multifunctional Catheter system | BIOTRONIK AG | LIT | Class II | |
| K241706 | MicroMatrix® UBM Particulate | ACell, Inc | KGN | Unclassified | |
| K241460 | Manual Wheelchair | Lichtmega Technology Co., Ltd. | IOR | Class I | |
| K241329 | SubtleSYNTH (1.x) | Subtle Medical Inc | QIH | Class II | |
| K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | GEI | Class II | |
| K241006 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | |
| K241000 | ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System; | Depuy Ireland UC | JWH | Class II | |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | LFL | Unclassified | |
| K233874 | tmCMF Solution | Techmah Cmf | JEY | Class II | |
| K233791 | Drivewire 24 Guidewire | Rapid Medical Inc. | MOF | Class II | |
| K241683 | Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314 | Boston Scientific Corporation | LIT | Class II | |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | SleepNet Corporation | BZD | Class II | |
| K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | Prosidyan, Inc. | FMF | Class II | |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | Medtronic Perfusion Systems | DTZ | Class II | |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Oticon Medical AB | PFO | Class II | |
| K240527 | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products Inc | NEU | Class II | |
| K240016 | IPL Hair Removal Device (YT01,YT02,YT03,YT04) | Shenzhen Jianrong Biomedical Electronics Co., Ltd. | OHT | Class II | |
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha Omega Services Inc | JAQ | Class II | |
| K233453 | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit | Life Technologies Corporation | QQX | Class II | |
| K232177 | Lightin System, Lightin, Lightin Generator | Solmedix Co., Ltd. | SBS | Class I | |
| K241372 | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ | Abbott Medical | MTD | Class II | |
| K241343 | IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140) | Shenzhen Lescolton Electrical Appliance Co., Ltd. | OHT | Class II | |
| K241316 | Zirconia Block | Hunan Hualian Special Ceramics Co., Ltd. | EIH | Class II | |
| K241019 | aprevo® TLIF-C Articulating System | Carlsmed, Inc. | MAX | Class II | |
| K240966 | Prima Plus Conical Implant System | Keystone Dental Inc. | DZE | Class II | |
| K240610 | deepLive | Damae Medical | NQQ | Class II | |
| K233937 | Ow100s | Softwave/Trt, LLC | PZL | Class II | |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) Ltd. | EKX | Class I | |
| K241293 | LED Light Therapy Device, ELIXIR MD™ | Yassen Wellness, LLC | GEX | Class II | |
| K240502 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K233584 | RhythmStar System | Rhythmedix | QYX | Class II | |
| K241660 | SiOxD® Wound Matrix | SiOxMed, LLC | QSZ | Unclassified | |
| K241649 | DUO1 and DUO2 | Zinnovi Inc. | MUH | Class II | |
| K241625 | Anatase Navi Disposable Instrument | Remex Medical Corp. | OLO | Class II | |
| K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare, LLC | EHD | Class II | |
| K241111 | AMT Suture Passer | Applied Medical Technology Inc | GCJ | Class II | |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K240120 | Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. | IOR | Class I | |
| K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) | Advanced Sterilization Products | JOJ | Class II | |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) | Advanced Sterilization Products | MLR | Class II | |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | Ethicon Endo-Surgery Inc | GAG | Class II |