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 |
|---|---|---|---|---|---|
| K252181 | AquaA | Fresenius Medical Care Renal Therapies Group, LLC | FIP | Class II | |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K251891 | Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. | ITI | Class II | |
| K251773 | Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) | Shenzhen Yongquan Medical Devices Co., Ltd. | NUC | Class II | |
| K251682 | MuscleView 2.0 | Springbok, Inc. (dba Springbok Analytics) | LNH | Class II | |
| K251072 | Segmentron Viewer | Dgnct LLC | QIH | Class II | |
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. | LCX | Class II | |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical, Ltd. | DSB | Class II | |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Corp. | GEI | Class II | |
| K243846 | Access anti-HAV | Siemens Healthcare Diagnostics Inc. | LOL | Class II | |
| K251957 | Coaptium Connect with Tissium Light | Tissium SA | SFD | Class II | |
| K251931 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies, Ltd. | QTZ | Class II | |
| K251892 | MAXXOS P.A.C.E. Foot & Ankle Plating System | Maxxos-Medical GmbH | HRS | Class II | |
| K251754 | Wearable Breast Pump (Model S33) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K251610 | qER-CTA (v1.0) | Qure.ai Technologies Inc | QAS | Class II | |
| K251394 | Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K251227 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | |
| K250960 | DUO Microcatheter | Rev Neuro, LLC | QJP | Class II | |
| K250928 | OmniTom Elite with PCD | Samsung HME America, Inc. | JAK | Class II | |
| K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | |
| K252528 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | |
| K252478 | Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port | Bard Access Systems, Inc. | LJT | Class II | |
| K251753 | GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics Inc | QYT | Class II | |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners LP | HAW | Class II | |
| K251250 | ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K251022 | 3D-Shaper | 3D-Shaper Medical S.L. | KGI | Class II | |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K250460 | WatchPAT400 (WP400) | Itamar Medical | MNR | Class II | |
| K250132 | Ureteral Access Sheath | Zhejiang Yigao Medical Technology Co., Ltd. | FED | Class II | |
| K250095 | All-Suture Dual Anchor System | Suturetech, Inc. | MBI | Class II | |
| K244038 | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd | DXT | Class II | |
| K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | MJN | Class II | |
| K251781 | Kala Mini 2.0 (Kala-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International SA | SBF | Class II | |
| K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | LGZ | Class II | |
| K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte., Ltd. | QIH | Class II | |
| K251545 | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment Guangxi Co., Ltd | ONF | Class II | |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | QAS | Class II | |
| K251510 | Symani Surgical System | Medical Microinstruments, Inc. | SAQ | Class II | |
| K251463 | EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | Abbott Medical | DQK | Class II | |
| K251444 | Endoskeleton™ Interbody Systems | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd | EHD | Class II | |
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | Clinical Laserthermia Systems AB | ONO | Class II | |
| K251168 | Image Suite | Eastman Kodak Company | LLZ | Class II | |
| K250893 | Ball Joint Guide Array (66295) | Medrad, Inc. | HAW | Class II | |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics Inc. | HKI | Class II | |
| K250353 | Oniris; Oniris Plus | Oniris | LRK | Class II | |
| K250064 | Dose+ (1.0) | MVISION AI Oy | MUJ | Class II | |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical Inc. | DXX | Class II | |
| K243700 | Apollo TMS Therapy System | Mag & More GmbH | OBP | Class II |