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 |
|---|---|---|---|---|---|
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | EOQ | Class II | |
| K253670 | SmartCT (R3.0 (L10)) | Philips North America LLC | OWB | Class II | |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | C.R. Bard Inc | KNT | Class II | |
| K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical, S.L. | PBX | Class II | |
| K261988 | Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical | NEW | Class II | |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | MBI | Class II | |
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic, Inc. | QJI | Class II | |
| K261569 | UbiqVue™ 2AYe Cardiac System (UX2253) | LifeSignals, Inc. | DRG | Class II | |
| K261471 | Zeta TMS Navigation System | Zeta Surgical Inc. | QFF | Class II | |
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | Pinkslip, LLC | NUC | Class II | |
| K261166 | Dia-Cem | Diadent Group International | EMA | Class II | |
| K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | PROCEPT BioRobotics Corporation | PZP | Class II | |
| K260539 | MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter | MedSource Labs, LLC | FOZ | Class II | |
| K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | DSH | Class II | |
| K253901 | Millipede88 Access Catheter | Perfuze | QJP | Class II | |
| K253899 | 3D-Anywhere | Provect.AI | LLZ | Class II | |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | DQK | Class II | |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | EBI | Class II | |
| K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | ITI | Class II | |
| K261191 | Alians Elbow S | Newclip Technics | HRS | Class II | |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | Roche Molecular Systems Inc | QEP | Class II | |
| K260750 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | MUJ | Class II | |
| K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | DPW | Class II | |
| K260278 | ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH | DWJ | Class II | |
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | SAN | Class II | |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | ODP | Class II | |
| K253751 | CXRDetectAI | NEUROCAREAI Inc (dba SaveLife.AI) | QFM | Class II | |
| K262045 | Luja Soft | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | Hoya Lamphun Ltd. | MVN | Class II | |
| K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | ITI | Class II | |
| K261163 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | INI | Class II | |
| K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | QIH | Class II | |
| K253942 | Pulmonex II Xenon System (132-503) | Mirion Technologies (Capintec), Inc. | IYT | Class II | |
| K261909 | Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | PCCA, Inc. | NUC | Class II | |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group,LLC | DYB | Class II | |
| K261465 | Indira Cloud Viewer | Indigo Technologies | LLZ | Class II | |
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | LZO | Class II | |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | Sterilance Medical (Suzhou) Inc. | QRL | Class II | |
| K253317 | Cytrans™ Elashield | GC America Inc. | LYC | Class II | |
| DEN250037 | TESSA Spatial Surgery System; INTELLIO Tablet (72205455) | Smith & Nephew, Inc. | SIQ | Class II | |
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | FRG | Class II | |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | FUJIFILM Corporation | FET | Class II | |
| K261867 | Xpert Carba-R | Cepheid | POC | Class II | |
| K261847 | iTero Lumina™ Pro | Align Technology, Inc. | NTK | Class II | |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott Medical | DQY | Class II | |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC | FDF | Class II | |
| K261129 | OrthoFit | Spident Co., Ltd. | DYH | Class II | |
| K260755 | OptraSCAN System | OptraSCAN Inc. | NOT | Class II | |
| K260596 | Collagen Wound Powder | Ventris Medical | KGN | Unclassified | |
| K260528 | OncoStudio | Oncosoft Inc. | QKB | Class II |