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 |
|---|---|---|---|---|---|
| K253963 | Cubresa BrainPET | Cubresa, Inc. | OUO | Class II | |
| K253694 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | |
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K251952 | Virasight | Virasoft Corporation | PSY | Class II | |
| DEN250040 | SportSuite Vision Software | Stryker Corp. | SIT | Class II | |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | Trimed Inc | HRS | Class II | |
| K261706 | Endomat Select (UP220) | Karl Storz SE & Co. KG | HIG | Class II | |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co.,Ltd. | GEX | Class II | |
| K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices | KWQ | Class II | |
| K261271 | Cable-Ready® Cable Grip System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | JDQ | Class II | |
| K260021 | cobas® BV/CV | Roche Molecular Systems Inc | PQA | Class II | |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular | NRY | Class II | |
| K262030 | Aventus Thrombectomy System | Inquis Medical, Inc. | QEZ | Class II | |
| K262006 | EnSite™ X EP System | Abbott Medical | DQK | Class II | |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd | OHS | Class II | |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | OVD | Class II | |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp | MYN | Class II | |
| K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health Pte. Ltd. | FMI | Class II | |
| K260338 | ThinkSono Guidance | Thinksono GmbH | QJU | Class II | |
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | QIH | Class II | |
| K260050 | WRAP System | Huneo, LLC | MNR | Class II | |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | PSY | Class II | |
| K252822 | Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. | PLR | Class II | |
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | CCK | Class II | |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | GCJ | Class II | |
| K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd | INI | Class II | |
| K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | Ambu A/S | GXY | Class II | |
| K253667 | Accoat Guide Wire | Sp Medical A/S | DQX | Class II | |
| K253662 | Lixi (Lxosfm1) | Luwi, LLC | MSC | Class II | |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland, Ltd | DQX | Class II | |
| K261199 | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K261085 | Rapid Vessel Occlusion (Rapid VO) | Ischemaview, Inc. | QAS | Class II | |
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | Embecta Medical II LLC | FMF | Class II | |
| K260199 | SLIM Microcatheter | Balt USA, LLC | QJP | Class II | |
| K254044 | Hearing assist | Meta Platform Technologies, LLC | SCR | Class II | |
| K253504 | Volnewmer™ | Classys Inc | GEI | Class II | |
| K262120 | Avara Viewer | Avara Software | LLZ | Class II | |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | Boston Scientific Corporation | ESW | Class II | |
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | FYA | Class II | |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | Howmedica Osteonics Corp., dba Stryker Orthopaedics | LPH | Class II | |
| K261306 | AI Contouring (VA10A) | Varian Medical Systems, Inc. | QKB | Class II | |
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | Acon Laboratories, Inc. | SCA | Class II | |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | ITI | Class II | |
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | FOZ | Class II | |
| K261031 | Poseidon St | Signus Medinzintechnik GmbH | MQP | Class II | |
| K260902 | Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System | Cochlear Americas | PFO | Class II | |
| K260880 | SedLine Sedation Monitor | Masimo Corporation | OLW | Class II | |
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | LSR | Class II |