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 |
|---|---|---|---|---|---|
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Medline ReNewal | NLH | Class II | |
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical | KNS | Class II | |
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | PTI | Class II | |
| K252260 | RELIEEV HSG Catheter (HSG7FA1) | LI Medical Corporation Ltd. | LKF | Class II | |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona Inc | NHA | Class II | |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | Acon Laboratories, Inc. | GTY | Class I | |
| K251674 | Fenom Flo™ FeNO Monitoring System | Mgc Diagnostics Corporation | MXA | Class II | |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | CGX | Class II | |
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. | JSM | Class I | |
| DEN240077 | MuReva OM™ | Mureva Phototherapy Inc. | SGQ | Class II | |
| K253365 | LuxCreo Flexible Partial Denture Resin | Luxcreo Inc. | EBI | Class II | |
| K253344 | Bellus-Q | Speclipse, Inc. | GEX | Class II | |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote S.p.A. | IYN | Class II | |
| K253304 | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) | Dongguan Lide Electric Appliance Co., Ltd | OHT | Class II | |
| K253219 | LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. | GEX | Class II | |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corp. | KNS | Class II | |
| K252762 | HALO AP Dx | Indica Labs LLC | QKQ | Class II | |
| K252610 | ZSFab Lumbar Interbody System | Zsfab Inc | MAX | Class II | |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | KTT | Class II | |
| K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited | PMC | Class II | |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | NPL | Class II | |
| K252161 | Hushd Avera | Good Sleep CO Pte, Ltd. | LRK | Class II | |
| K252004 | enCore Night Guard | Encore Guards | OBR | Unclassified | |
| K251932 | Spectra Platinum | Uzinmedicare Co., Ltd. | HGX | Class II | |
| K251798 | Rct700 | Ray Co., Ltd. | OAS | Class II | |
| K251550 | Nx01 (Nx01) | Naox Technologies SAS | OMC | Class II | |
| K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | KPS | Class II | |
| K251070 | Akura Thrombectomy System | Akura Medical | QEW | Class II | |
| K250694 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | QAS | Class II | |
| K250635 | FEops HEARTguide Simulation Application | Feops NV | QQI | Class II | |
| K253407 | NeVa PV Thrombectomy Device | Vesalio | QEX | Class II | |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | F Care Systems USA | GEI | Class II | |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | NUH | Class II | |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | Boston Scientific Corporation | QEZ | Class II | |
| K252366 | a2z-Unified-Triage | A2z Radiology Ai, Inc. | QAS | Class II | |
| K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Healthcare | IYN | Class II | |
| K251631 | The BAG manual resuscitator and accessories | Laerdal Medical a/S | BTM | Class II | |
| K250769 | Dakota LP System | Precision Spine, Inc. | ODP | Class II | |
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | DSB | Class II | |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.r.l. | DTZ | Class II | |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & Co. KG | GCJ | Class II | |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy Inc. | EBI | Class II | |
| K252696 | Legacy | Phasor Health, LLC | HBG | Class II | |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd. | IOR | Class I | |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | ODP | Class II | |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | HRX | Class II | |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd | INI | Class II |