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 |
|---|---|---|---|---|---|
| K191838 | Clearform Aligners | Motor City Lab Works | NXC | Class II | |
| K191735 | CPT Hip System | Zimmer GmbH | JDI | Class II | |
| K191680 | AZUR Vascular Plug | Terumo Cardiovascular Systems Corporation | KRD | Class II | |
| K191657 | Bioland Blood Glucose Monitoring System | Bioland Technology Ltd. | NBW | Class II | |
| K191612 | Encision AEM Monopolar Laparoscopic Instruments and Accessories | Encision Incorporated | GEI | Class II | |
| K200379 | Super Sheath | Togo Medikit Co., Ltd. | DRE | Class II | |
| K193530 | Deklene MAXX | Teleflex Medical | GAW | Class II | |
| K193491 | restor3d Metallic Interference Screw | restor3d, Inc. | HWC | Class II | |
| K193061 | G3 40 Radiopaque Bone Cement | G21, S.r.l. | LOD | Class II | |
| K193059 | G1 40 Radiopaque Bone Cement | G21, S.r.l. | LOD | Class II | |
| K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical Ltd | KNS | Class II | |
| K191856 | Compression Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. | JOW | Class II | |
| K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K191658 | IV Sets not made with PVC | B.Braun Medical, Inc. | FPA | Class II | |
| K191057 | Park's Pectus System | Tdm Co., Ltd. | HRS | Class II | |
| K200418 | Vivix-S Vw | Vieworks Co., Ltd. | MQB | Class II | |
| K200406 | Evolve Breast Pump | Hygeia II Medical Group, Inc. | HGX | Class II | |
| K200198 | Wirion | Cardiovascular Systems Incorporated | NTE | Class II | |
| K200113 | LINK TrabecuLink Tibial Cones | Waldemar Link GmbH & Co. KG | MBH | Class II | |
| K200094 | speX LP Support Catheter | ReFlow Medical, Inc | DQY | Class II | |
| K193658 | Viz ICH | Viz. Ai, Inc. | QAS | Class II | |
| K193558 | HEALICOIL Knotless Suture Anchors | Smith & Nephew, Inc. | MAI | Class II | |
| K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | BioFire Diagnostics, LLC | PEN | Class II | |
| K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | KTI | Class II | |
| K191876 | PulmoScan | Cognita Labs LLC | PNV | Class II | |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | BSZ | Class II | |
| K200443 | EndoTool IV 1.10 | Monarch Medical Technologies | NDC | Class II | |
| K200433 | iBalance UKA Tibial Tray Implant | Arthrex GmbH | HSX | Class II | |
| K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | Johnson & Johnson Vision Care, Inc. | LPL | Class II | |
| K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill | Zimmer GmbH | HSX | Class II | |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | IYO | Class II | |
| K193582 | SterilContainer S2 System | Aesculap Inc | KCT | Class II | |
| K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) | MXC | Class II | |
| K192753 | NeuralScan System | Medeia Inc | GWQ | Class II | |
| K192272 | Wolf445nm | A.R.C. Laser GmbH | GEX | Class II | |
| K192007 | TheraBase, TheraBase Ca | Bisco Inc | EMA | Class II | |
| K191753 | Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) | MEDLINE INDUSTRIES, LP - Northfield | LZA | Class I | |
| K200522 | AERO CHROME* Breathable Performance Surgical Gowns | O&M Halyard, Inc. | FYA | Class II | |
| K200385 | Continuum Pacs | Integrated Ophthalmic Systems, Inc. | NFJ | Class II | |
| K200110 | SANDRO Dual | WONTECH Co., Ltd. | GEX | Class II | |
| K200097 | Response BandLoc Spinal Fixation | Orthopediatrics Corp | OWI | Class II | |
| K193486 | Epic 980 | Biolase, Inc. | GEX | Class II | |
| K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K192713 | Altera Filter and HME/Filter | Meditera Tibbi Malzeme San ve Tic AS | CAH | Class II | |
| K191827 | Sunmed Disposable Angio-Closure Pads | Sunny Medical Device (Shenzhen) Co., Ltd. | DXC | Class II | |
| K191705 | OptikView GUP2103CMI | The Linden Group Corp. | PGY | Class II | |
| K190767 | AnatomicAligner | The Methodist Hospital Research Institute D/B/A Houston | LLZ | Class II | |
| K190495 | Transferrin | Biosystems S.A. | DDG | Class II | |
| K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | NUH | Class II |