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 |
|---|---|---|---|---|---|
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | SleepNet Corporation | BZD | Class II | |
| K251831 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | QHW | Class II | |
| K251458 | Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co.,Ltd. | ITI | Class II | |
| K251357 | Esperance pHLO Aspiration System | Phenox Inc | NRY | Class II | |
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | LBI | Class II | |
| K251254 | Ignite RF System | Inmode Ltd. | GEI | Class II | |
| DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | Bridge to Life Ltd | SGY | Class II | |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | Philips Medical Systems Nederland B.V. | MOS | Class II | |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab, Inc. | IYE | Class II | |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic, Inc. | QJI | Class II | |
| K253511 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | KRD | Class II | |
| K252958 | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | GXN | Class II | |
| K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | OXO | Class II | |
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | LZC | Class I | |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | ODP | Class II | |
| K251996 | ENTire IRE System | ENTIRE MEDICAL Ltd | GEI | Class II | |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic, S.A. de C.V. | BTT | Class II | |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Corp. | GCJ | Class II | |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical Inc. | KPS | Class II | |
| K253248 | Bright Cavity Liner | DMP Dental Industry S.A. | EJK | Class II | |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | LZA | Class I | |
| K252461 | Swedge™ Pedicle Screw Fixation System Bezier Rod | Spinal Resources Inc | NKB | Class II | |
| K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics | QNI | Class II | |
| K253167 | Any-Paste | Mediclus Co., Ltd | KIF | Class II | |
| K252962 | DYNAMIS™ Navigation System | Promethean Restorative Inc. | OLO | Class II | |
| K252913 | Break Wave | Sonomotion, Inc. | LNS | Class II | |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd | FXX | Class II | |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex GmbH | HRS | Class II | |
| K251988 | Boston iFace (Boston iFace) | Boston Aesthetics Inc | GEI | Class II | |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | IOR | Class I | |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | EBW | Class I | |
| K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | QHE | Class II | |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | GEH | Class II | |
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | EFB | Class I | |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | Foshan Topmed Dental Co., Ltd. | EFB | Class I | |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd | DXN | Class II | |
| K250890 | SBC1 Cream | SiOxMed, LLC | FRO | Unclassified | |
| K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | GWF | Class II | |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | PHX | Class II | |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co.,Ltd | EIH | Class II | |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies Inc | DXQ | Class II | |
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | GFO | Class II | |
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows | SAH | Class II | |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | Ningbo Ranor Medical Technology Co., Ltd. | DXN | Class II | |
| K253075 | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) | Suzhou Sweetrich Vehicle Industry Technology Co,Ltd. | INI | Class II | |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery Inc | OXC | Class II | |
| K252847 | NextAR Hip Platform | Medacta International SA | SBF | Class II | |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace Inc | DQX | Class II | |
| K252589 | Corvair Monza | AliveCor | MHX | Class II | |
| K252339 | iotaSOFT® Insertion System | Iotamotion Inc | QQH | Class II |