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 |
|---|---|---|---|---|---|
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K252013 | EnSite™ X EP System | Abbott Medical | DQK | Class II | |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corp. | OCX | Class II | |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. | PCH | Class II | |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | Stryker Corp. | OLO | Class II | |
| K251868 | Panther Fusion GI Bacterial Assay | Hologic, Inc. | PCH | Class II | |
| K251812 | Steripath® Flow™ Blood Collection System | Magnolia Medical Technologies, Inc. | JKA | Class II | |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical LLC | PLF | Class II | |
| K251789 | EMBOTRAP III Revascularization Device | Neuravi Limited | NRY | Class II | |
| K251527 | Brain WMH | Quantib B.V. | QIH | Class II | |
| K251512 | Hi bebe super (BT-150B) | Bistos co., Ltd. | HGX | Class II | |
| K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd | KIF | Class II | |
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare SRL | DZE | Class II | |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | DQA | Class II | |
| K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis, Inc | OVE | Class II | |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) | Yung Sheng Optical Co., Ltd. | LPL | Class II | |
| K243785 | Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced | Medtronic, Inc. | BTR | Class II | |
| DEN250016 | Essilor® Stellest® | Essilor of America, Inc. | QUR | Class II | |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | Boston Scientific Corporation | FGB | Class II | |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty Ltd | IZQ | Class II | |
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories | OOE | Class II | |
| K252680 | Celerity™ 20 HP Biological Indicator | STERIS Corporation | FRC | Class II | |
| K252227 | Pounce(TM) Sheath | Surmodics, Inc. | DYB | Class II | |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | KNW | Class II | |
| K251734 | ProVee Video Processing Unit (PV-003) | Proverum Limited | FET | Class II | |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc | MUH | Class II | |
| K250792 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | Alma Lasers Ltd. | GEX | Class II | |
| K250045 | uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K244029 | Robopera (Er-R-002); Robopera (Er-R-003) | Endorobotics Co., Ltd. | FDF | Class II | |
| K243910 | Retraxil | Kulzer GmbH | MVL | Unclassified | |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd | EBF | Class II | |
| K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | NEW | Class II | |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | Olympus Winter & Ibe GmbH | GEI | Class II | |
| K251987 | Rapid Aortic Measurements | Ischemaview, Inc. | QIH | Class II | |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences LLC | KRH | Class II | |
| K251973 | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | OKJ | Class II | |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | EOQ | Class II | |
| K251483 | SwiftSight-Brain | AIRS Medical Inc. | QIH | Class II | |
| K251140 | Zenflow Spring Scope | Zenflow, Inc. | FAJ | Class II | |
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Canyon Medical Inc. | KRD | Class II | |
| DEN240080 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | SFU | Class II | |
| K252315 | Santreva™-ATK Endovascular Revasculariztion Catheter | AngioSafe | PDU | Class II | |
| K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | GCJ | Class II | |
| K250388 | Endoflator + | Karl Storz SE & Co. KG | HIF | Class II | |
| K250205 | Babio® Virus Transport Kit (Non-inactivating) | Jinan Babio Biotechnology Co.,Ltd. | JSM | Class I | |
| K243645 | IC-Flow™ Imaging System 2.0 | Diagnostic Green GmbH | IZI | Class II | |
| K252662 | UniBur | Nakanishi Inc. | HBE | Class II | |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc | HTY | Class II |