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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K211399 | Sterile Level 3 Surgical Gown | Barco Tekstil Sanayi ve Ticaret A.S. | FYA | Class II | |
| K211346 | Blue 400 | Carl Zeiss Meditec Inc | QFX | Class II | |
| K203680 | BioFire JI Control Panel M420 | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K221823 | Cionic Neural Sleeve NS-100 | Cionic | GZI | Class II | |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corp. | KOI | Class II | |
| K220671 | Manual Wheelchair | Hebei Ruilangde Medical Equipment Technology Group Co., Ltd. | IOR | Class I | |
| K220184 | Pump Alignment Syringe | Jiangsu Caina Medical Co., Ltd | FMF | Class II | |
| K213881 | Celerity Incubator | STERIS Corporation | FRC | Class II | |
| K213773 | Insufflation Retention Device | BPEndo, LLC | FDF | Class II | |
| K213158 | Syringe with permanently attached needle | Berpu Medical Technology Co., Ltd. | FMF | Class II | |
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, S.L. | DZE | Class II | |
| K211543 | Wei Nasal Jet Tube | Well Lead Medical Co. Ltd | BTR | Class II | |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | KWY | Class II | |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Vieworks Co., Ltd. | MQB | Class II | |
| K221363 | AF Laser | ShenB Co., Ltd. | PDZ | Class II | |
| K221037 | TruDi Shaver Blade | Acclarent Inc | PGW | Class II | |
| K220956 | Libby Echo:Prio | Dyad Medical, Inc. | QIH | Class II | |
| K220679 | Pediatric Nailing Platform Femur | Orthopediatrics Corp | HSB | Class II | |
| K220161 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd | KPI | Class II | |
| K220039 | AutoSeg | Ai Medic, Inc. | LLZ | Class II | |
| K214080 | Pentaflush | Pentaferte Italia S.r.l. | NGT | Class II | |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | KTI | Class II | |
| K212178 | Root Apex Locator | Foshan Coxo Medical Instrument Co., Ltd. | LQY | Unclassified | |
| K222037 | Selectra Lead Implantation System | BIOTRONIK AG | DQY | Class II | |
| K221516 | ARTIS icono (Ceiling Configuration) | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K221151 | Beauty LED Mask, Model: KFB265 | Hunan Guangye Biotechnology Co., Ltd. | OHS | Class II | |
| K220943 | Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim | Eco Medi Glove Sdn Bhd | LZA | Class I | |
| K220815 | BrainInsight | Hyperfine, Inc | QIH | Class II | |
| K220777 | Surgical face mask | Hubei Qianjiang Kingphar Medical Material Co., Ltd | FXX | Class II | |
| K213761 | Joule diVa System | Sciton, Inc. | GEX | Class II | |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | KRA | Class II | |
| K213409 | ZEUS System (Zio Watch) | iRhythm Technologies, Inc. | DQK | Class II | |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | DXH | Class II | |
| K212215 | Tiche PTA Balloon Dilatation Catheter | BrosMed Medical Co.,Ltd. | LIT | Class II | |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | Sedecal S.A. | IZL | Class II | |
| K221148 | Vivid iq | GE Healthcare | IYN | Class II | |
| K221147 | Vivid T8, Vivid T9 | GE Healthcare | IYN | Class II | |
| K212614 | Ultrasonic Scalpel System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | LFL | Unclassified | |
| K212509 | OSSIX Breeze | Datum Dental, Ltd. | NPL | Class II | |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed Oy | MUE | Class II | |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | JEY | Class II | |
| K221229 | Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves | Zibo Blue Sail Health Technology Co., Ltd | LZA | Class I | |
| K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | Becton Dickinson & Co | QTI | Class II | |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | MQB | Class II | |
| K221814 | OK Handpiece | Jaintek Co.,Ltd | EFB | Class I | |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | LFL | Unclassified | |
| K221433 | Facet 28G Universal Lancet | Facet Technologies, LLC. | QRK | Class II | |
| K221030 | Model 9100 PFT/DICO | Vitalograph Ireland Ltd. | BTY | Class II | |
| K220970 | Renuvion APR Handpiece | Apyx Medical Corporation (Formerly Bovie Medical Corporation | GEI | Class II | |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Ltd | HQF | Class II |