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 |
|---|---|---|---|---|---|
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., Ltd. | GCJ | Class II | |
| K254121 | Colli-Pee•Dx Urine Collection Kit | DNA Genotek Inc. | SIH | Class II | |
| K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co.,Ltd | IRP | Class II | |
| K253192 | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | SAO | Class II | |
| K253115 | Lars Acj | Movmedix S.A.S | HTN | Class II | |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | Penumbra Inc. | NRY | Class II | |
| K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | ERBE Elektromedizin GmbH | GEH | Class II | |
| K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | QUW | Class II | |
| K261549 | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | QJP | Class II | |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K260802 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise N.V. | QHE | Class II | |
| K260748 | ES-Series | E-Scopics | IYN | Class II | |
| K260564 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | GEI | Class II | |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare Ltd. | NUC | Class II | |
| K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | NKB | Class II | |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | |
| K261352 | 2D Hip Planning Software | One Ortho | LLZ | Class II | |
| K260332 | EchoNext | Pathwai, Inc | QXO | Class II | |
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | IPF | Class II | |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | INI | Class II | |
| K253066 | ELEOS™ with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. | QZZ | Class II | |
| K251944 | Lipocosm Harmonic System | Lipocosm, LLC | QPB | Class II | |
| K261492 | FieldFlex Steerable Sheath | Centerpoint Systems LLC | DYB | Class II | |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | HRS | Class II | |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech LLC | QYT | Class II | |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | LHI | Class II | |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc | DQY | Class II | |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences LLC | DXC | Class II | |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II | |
| K254086 | EyeBOX SNAP | Oculogica Inc. | QEA | Class II | |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA Inc | GEI | Class II | |
| K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | OXO | Class II | |
| K253204 | Catalyze | BioTissue Holdings Inc. | KGN | Unclassified | |
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies Inc | FLL | Class II | |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | HWC | Class II | |
| K251684 | Alma TED+ System | Alma Lasers Ltd. | OAP | Class II | |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | LPH | Class II | |
| K261519 | Sonio Suspect | Sonio | POK | Class II | |
| K261510 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | QHE | Class II | |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | HGX | Class II | |
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | Diasorin Inc. | LOM | Class II | |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co, Ltd. | GEX | Class II | |
| K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | OAS | Class II | |
| K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co.,Ltd. | QIH | Class II | |
| K254209 | Radius VSM and Accessories | Masimo Corporation | MHX | Class II | |
| K253994 | TroKit Laparoscope Lens Wiper | Trocare, LLC | GCJ | Class II | |
| K253984 | Instrument Exit Point on Touch Surgery™ Aide | Medtronic, Inc. | SFE | Class II | |
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | NFJ | Class II | |
| K253602 | Precision S 4K Sinuscope | Stryker Corp. | GWG | Class II |