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 |
|---|---|---|---|---|---|
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Medtronic Xomed, Inc. | ETN | Class II | |
| K213200 | Solus Gold Embolization Device | Artio Medical, Inc. | KRD | Class II | |
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (HangZhou) CO., Ltd. | KNS | Class II | |
| K203839 | WatchPAT200U (WP200U) | Itamar Medical | MNR | Class II | |
| K220627 | SURGIVISIO Device | Ecential Robotics | OWB | Class II | |
| K220529 | Merits P335 Powered Wheelchair | Merits Health Products, Inc. | ITI | Class II | |
| K220473 | CELERITY 20 HP Challenge Pack | STERIS Corporation | FRC | Class II | |
| K220275 | EMERGE Anterior Cervical Plate System | Evolution Spine, LLC | KWQ | Class II | |
| K220228 | Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs | Shandong Blue Sail Health Technology Co., Ltd | LZA | Class I | |
| K220153 | Needle Stimulator (Model: RJNS6-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | BWK | Unclassified | |
| K214016 | 15L Cycler Drainage Bag | Baxter Healthcare Corporation | KDJ | Class II | |
| K213965 | BeautiBond Xtreme | Shofu Dental Corp. | KLE | Class II | |
| K213834 | Cardio Flow Peripheral Guide Wire | Cardio Flow, Inc. | DQX | Class II | |
| K213563 | DePuy Synthes Radial Head Replacement System | DePuy Synthes | KWI | Class II | |
| K212939 | Vintage Prime Press | Shofu Dental Corp. | EIH | Class II | |
| K212891 | TempSure System | Cynosure, LLC | GEI | Class II | |
| K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, L.L.C. | OVD | Class II | |
| K212371 | F&P Evora Full Face Mask | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster Inc | MTD | Class II | |
| K211132 | ARISTE AB Mesh | Ariste Medical, LLC | FTL | Class II | |
| K210823 | LYMA Laser | Lyma Life Ltd. | OHS | Class II | |
| K210171 | Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) | Sichuan Youkede Medical Equipment Co.,Ltd | FLL | Class II | |
| K203530 | Albumin BCP2 | Abbott Ireland Diagnostics Division | CJW | Class II | |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown | Dukal LLC | FYA | Class II | |
| K213948 | OxyMinder | Bio-Med Devices, Inc. | CCL | Class II | |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | The Ureteral Stent Company, Inc. | FAD | Class II | |
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac Ltd. | HQD | Class II | |
| K210489 | SICtapered & SICvantage tapered | Sic Invent AG | DZE | Class II | |
| K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps | Modern Medical Equipment Manufacturing Ltd. | GEI | Class II | |
| K220726 | K Clear | Kline Europe GmbH | NXC | Class II | |
| K220426 | Fiber Dust PRO | Quanta System Inc. | GEX | Class II | |
| K220324 | AccuFit Lateral 2-Hole Plate | Precision Spine, Inc. | KWQ | Class II | |
| K213823 | Intera Refill Kit | Intera Oncology | PTI | Class II | |
| K213779 | Customize | 3D-Side | QIH | Class II | |
| K213623 | iTEAR100 Neurostimulator | Olympic Ophthalmics | QKV | Class II | |
| K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.p.A. | IYO | Class II | |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) | Healgen Scientific LLC | GTY | Class I | |
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit | MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA Cellmyx | MUU | Class II | |
| K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | ODP | Class II | |
| K213314 | CerusEndo Microcatheter (027) | Cerus Endovascular, Inc. | QJP | Class II | |
| K213121 | Disposable Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | LZA | Class I | |
| K212955 | Fit Pro Breast Pump | Hygeia II Medical Group, Inc. | HGX | Class II | |
| K212709 | VoqX Electronic Stethoscope | Sanolla, Ltd. | DQD | Class II | |
| K212461 | Vitek Ms Prime | bioMerieux, Inc. | QBN | Class II | |
| K220049 | Optimotion Implants Porous Metal-Backed Patella | Optimotion Implants, LLC | MBH | Class II | |
| K214043 | BriefCase | Aidoc Medical Ltd. | QFM | Class II | |
| K213907 | CareGUARD Sterilization Wrap | Care Essentials Pty., Ltd. | FRG | Class II | |
| K213894 | DWFritz ASM2000 | Dwfritz Automation, Inc. | FXX | Class II | |
| K213790 | Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 | Mobility Source Medical Technology Co., Ltd. | IOR | Class I | |
| K212393 | OPN NC PTCA Dilatation Catheter | Sis Medical AG | LOX | Class II |