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 |
|---|---|---|---|---|---|
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | JAK | Class II | |
| DEN250042 | CaRi-Heart | Caristo Diagnostics | SIU | Class II | |
| K262474 | ND Needle Guidance System | Accurate Access, LLC | ITX | Class II | |
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | LOX | Class II | |
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | DRE | Class II | |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K261105 | Powered Aventus Thrombectomy System™ | Inquis Medical, Inc. | QEZ | Class II | |
| K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | FGE | Class II | |
| K260529 | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co.,Ltd. | IRP | Class II | |
| K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) | Plus EV Holdings, Inc. D/B/A Intimate Rose | OSD | Class II | |
| K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | MSX | Class II | |
| K253576 | CorVista System® with PCWP Add-On | Analytics for Life Inc. | DQK | Class II | |
| K260382 | MONARCH™ Platform (MON-000008) | Auris Health, Inc | EOQ | Class II | |
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | JEY | Class II | |
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | LLZ | Class II | |
| K262383 | LumenCare Azure | Nucletron BV | JAQ | Class II | |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | Philips Medical Systems Nederland B.V. | MOS | Class II | |
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | KWL | Class II | |
| K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | DRA | Class II | |
| K262152 | Vs-370Cf, Vs-370Ct | Vision Medical Inc | FCX | Class II | |
| K262121 | Ion-L Navigated Instruments | Surgentec LLC | OLO | Class II | |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | OBJ | Class II | |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) | JTN | Class II | |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | KRD | Class II | |
| K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics Inc. | LDP | Class II | |
| K261349 | SwiftMR | AIRS Medical Inc. | QIH | Class II | |
| K261312 | Temporary Keratoprosthesis (QuickSet TKP™) | Eyekon Medical, Inc. | MLP | Class II | |
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | Cook Ireland Ltd. | KTI | Class II | |
| K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | Hycor Biomedical | DHB | Class II | |
| K261024 | TMINI Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc | ITX | Class II | |
| K260948 | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | IRP | Class II | |
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | OHS | Class II | |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration) | MANTIZ Co.,Ltd. | NKB | Class II | |
| K260259 | DiscreetDuo™ Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K260192 | Diana | ROPCA ApS | QIH | Class II | |
| K254180 | PerfusiX-Imaging | LIMIS Development B.V. | OWN | Class II | |
| K253943 | Tiger 2 System | Zavation Medical Products, LLC | NKB | Class II | |
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | FRN | Class II | |
| K253541 | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | GCJ | Class II | |
| K253452 | Accuro 3S | Rivanna Medical, Inc | IYO | Class II | |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | IOR | Class I | |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | LLZ | Class II | |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | NBW | Class II | |
| K261853 | Gepotidacin GEP 10 µg | Liofilchem S.r.l. | JTN | Class II | |
| K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology Inc. | OAS | Class II |