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 |
|---|---|---|---|---|---|
| K200967 | mCare(R) Powder Free Nitrile Orange Examination Gloves | Mercator Medical (Thailand) Ltd. | LZA | Class I | |
| K201212 | Voyant Open Fusion Device | Applied Medical Resources Corp | GEI | Class II | |
| K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc | ETD | Class II | |
| K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | QHE | Class II | |
| K200441 | UroLift Advanced Tissue Control (ATC) System | Neotract Inc | PEW | Class II | |
| K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker Corp. | HRS | Class II | |
| K200107 | epoc Blood Analysis System | Epocal Inc | CHL | Class II | |
| K193150 | Latex Examination Powder Free Glove, Aloe Vera | Top Glove Sdn. Bhd. | LZA | Class I | |
| K193003 | NemoCast | Software Nemotec, S.L. | PNN | Class II | |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd | JIN | Class I | |
| K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | MSX | Class II | |
| K192550 | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H | 3M Company | FRC | Class II | |
| K191491 | EZ-Cover | Medxpress.pro | ITX | Class II | |
| K191461 | Exofin Fusion Skin Closure System | Chemence Medical Inc. | OMD | Class II | |
| K201223 | LZI Tramadol Enzyme Immunoassay | Lin-Zhi International Inc | DJG | Class II | |
| K201214 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | Medos International SARL | MBI | Class II | |
| K200883 | CarboClear® Cervical Plate System | CarboFix Orthopedics Inc. | KWQ | Class II | |
| K200277 | Livongo Blood Glucose Monitoring System (BG1000) | Livongo Health, Inc. | NBW | Class II | |
| K200227 | Journey II XR Knee Instrument | Smith & Nephew, Inc. | JWH | Class II | |
| K200104 | Oxylight | Raja Trading Company, Inc. | GEX | Class II | |
| K200057 | bioli lOL Delivery System | AST Products, Inc. | MSS | Class I | |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Ever Global (Vietnam) Enterprise Corporation | LZC | Class I | |
| K201175 | StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc | HAW | Class II | |
| K200974 | QLAB Advanced Quantification Software | Philips Health Care | QIH | Class II | |
| K200929 | Hair Growth System | Xuzhou Kernel Medical Equipment Co Ltd | OAP | Class II | |
| K200907 | Thales 3D Mr Scanner | LAP GmbH Laser Applikationen | IYE | Class II | |
| K200721 | Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) | DQY | Class II | |
| K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant | CC Wellness LLC | NUC | Class II | |
| K200514 | Cardioblate Gemini-s Surgical Ablation Device | Medtronic, Inc. | OCL | Class II | |
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | Chembio Diagnostic Systems, Inc. | QFO | Class II | |
| K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | MJN | Class II | |
| K200268 | Halo™ Single-Loop Snare Kit | Argon Medical Devices, Inc | MMX | Class II | |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical, LP | PKC | Class II | |
| K193021 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | LNH | Class II | |
| K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | GXR | Class II | |
| K201202 | MI View&GO | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | NeoCoil, LLC | MOS | Class II | |
| K200911 | MIRA Adapter | Phakos | HRN | Class II | |
| K200889 | iMac 27 & PL 4.0 | Quantum-Spectra, LLC | PGY | Class II | |
| K200684 | gastroduodenal FTRD Set | Ovesco Endoscopy AG | PKL | Class II | |
| K200532 | StarPore | Anatomics Pty, Ltd. | JOF | Class II | |
| K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism | Bausch + Lomb, Incorporated | LPL | Class II | |
| K200322 | Altus Spine Pedicle Screw System | Altus Partners | NKB | Class II | |
| K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | Black Forest Medical GmbH | HBL | Class II | |
| K193307 | Hip7 | Brainlab, Inc. | OLO | Class II | |
| K192779 | Bunny Wax Personal Lubricant | Reoxcyn, LLC | NUC | Class II | |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | Hartalega Sdn Bhd | KGO | Class I | |
| K200540 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | ConMed Corporation | GXY | Class II |