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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
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	2,732

176,529 records, page 1226 of 3531

510(k) clearances, page 1226 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062969	Medline Sterile Disposable Surgical Gowns	MEDLINE INDUSTRIES, LP - Northfield	FYA	Class II	2006-12-14
K062947	High Speed Air Turbine Handpiece, Models Super-Air and Super-Qd Series	Peng Lim Enterprise Co., Ltd.	EFB	Class I	2006-12-14
K062897	C-U2	Cefla S.C.R.L.	EIA	Class I	2006-12-14
K062891	Proton Therapy System	Indiana University Cyclotron Facility	LHN	Class II	2006-12-14
K062770	Copilot Health Management System	Abbott Medical	NBW	Class II	2006-12-14
K062676	Ruike, Model 3331	Shanghai Ruike Sports Goods Co., Ltd.	INI	Class II	2006-12-14
K062640	Stryker Navigation System - Cranial Module, Model 6000-650-000	Stryker Corp.	HAW	Class II	2006-12-14
K062582	Supracor Balloon Catheter	Abiomed, Inc.	DSP	Class II	2006-12-14
K062380	Flosimple Arthroscopy Pump A120	Novanta Medical GmbH	HRX	Class II	2006-12-14
K062333	Laimad	Steven Lamberg, D.D.S	LRK	Class II	2006-12-14
K062013	Cellsearch Circulating Tumor Cell Kit	Veridex, LLC	NQI	Class II	2006-12-14
K061901	Ino Therapeutics Inomax Ds (Delivery System), Model 10003	Mallinckrodt Manufacturing LLC	MRN	Class II	2006-12-14
K061283	Pulmolife	Micro Medical, Ltd.	BZG	Class II	2006-12-14
K063479	Arthrex Pushlock	Arthrex GmbH	HWC	Class II	2006-12-13
K063426	V.a.c. Ats Large (1000 Ml) Canister with Gel, Models M6275093/5, M6275093/10	KCI USA, Inc.	OMP	Class II	2006-12-13
K063343	Bioptigen Spectral Domain Ophthalmic Imaging System	Bioptigen, Inc.	HLI	Class II	2006-12-13
K062922	Modification to Aquadex Flexflow System	Chf Solutions, Inc.	KDI	Class II	2006-12-13
K062856	Tf Rotary Nickel Titanium File	Ormco Corp.	EKS	Class I	2006-12-13
K062845	Modular Replacement Elbow System	Howmedica Osteonics Corp	HSD	Class II	2006-12-13
K062708	Quanta Lite Celiac Dgp Screen	Inova Diagnostics, Inc.	MST	Class II	2006-12-13
K062692	Bis Bilateral Sensor	Aspect Medical Systems, Inc.	GXY	Class II	2006-12-13
K062612	Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04	Rayner Surgical, Inc.	MSS	Class I	2006-12-13
K062217	Aeskulska Beta2-Glyco-a	Aesku, Inc.	MSV	Class II	2006-12-13
K062177	Zoll E Series with Real CPR Help	ZOLL Medical Corporation	MKJ	Class III	2006-12-13
K061774	Nfix II Pedicle Screw System	N Spine, Inc.	NQP	Class II	2006-12-13
K063657	Vascutrak Pta Dilation Catheter	Ymed, Inc.	PNO	Class II	2006-12-12
K063557	Peak Bond, Model 5133	Ultradent Products Inc.	KLE	Class II	2006-12-12
K063513	Echelon Mr-Rcc-150 Cardiac Coil	FUJIFILM Healthcare Americas Corporation	MOS	Class II	2006-12-12
K063505	Visualase Envision Software System	Biotex, Inc.	LLZ	Class II	2006-12-12
K063414	Modification to: Fmp Metal/metal Acetabular Insert, Models 499-28, 499-34, 499-38	Encore Medical, LP	KWA	Class III	2006-12-12
K063392	Imco-Stat	Imco Technologies	LLZ	Class II	2006-12-12
K063337	Opal-Rad	Viztek, LLC	LLZ	Class II	2006-12-12
K063274	Acculoc Breast Localization System	Northwest Medical Physics Equipment, Inc.	IYE	Class II	2006-12-12
K063253	Rchive Pacs	Sobha Renaissance Information Technology Pvt, Ltd.	LLZ	Class II	2006-12-12
K063221	Medweb Advanced 3D Web Pacs	Nexsys Electronics	LLZ	Class II	2006-12-12
K063080	Tripole 8C and 16C and Exclaim 8 Lamitrode Series Leads	Abbott Medical	GZB	Class II	2006-12-12
K063028	Vectorvision Hip Sr	Brainlab, Inc.	HAW	Class II	2006-12-12
K062951	Tap III Anti-Snoring Device	Airway Management Inc.	LRK	Class II	2006-12-12
K061889	Biostar Oia Shigatox	Inverness Medical-Biostar, Inc.	GMZ	Class I	2006-12-12
K061033	Miltex Rigid Sterilization Container System, (47 Components)	Miltex, Inc.	KCT	Class II	2006-12-12
K052465	Reduced Energy Pediatric Electrode Pads for the Samaritan AED and Pad, Models Sde 251, Spp 351	HeartSine Technologies Ltd	MKJ	Class III	2006-12-12
K052298	Cystoglide Introducer Sheath	Percutaneous Systems, Incorporated	KNY	Class II	2006-12-12
K063428	Xia Stainless Steel Spinal System	Howmedica Osteonics Corp	NKB	Class II	2006-12-11
K063402	Wick Electrode, Model M019260	Intelligent Hearing Systems Corp.	GXY	Class II	2006-12-11
K063379	Amedica Drug Screen Thc, Coc, Opi, Amp, Met, Pcp, Mdma, Bar, Bzo, M, Models C1210, C1220	Amedica Biotech, Inc.	DKZ	Class II	2006-12-11
K063239	Lifeshield Latex-Free Gravitech Flow Controller i.v. Sets, Models 17528, 17527, 17525 & 17526	Abbott Medical	FPK	Class II	2006-12-11
K063180	Isecure Syringe Cartridge Holder	Abbott Medical	IQG	Class I	2006-12-11
K063087	Modification to Model 750 Series Monitor	Cas Medical Systems, Inc.	MWI	Class II	2006-12-11
K062795	Mugard Mucoadhesive Oral Wound Rinse	Access Pharmaceuticals, Inc.	OLR	Unclassified	2006-12-11
K062791	Usi Dental Scaler, 25Xxx Series	Ultrasonic Services, Inc.	ELC	Class II	2006-12-11