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 2184 of 3531

510(k) clearances, page 2184 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941770	Duraprene Sterile Synthetic Surgeon's Gloves	Baxter Healthcare Corporation	KGO	Class I	1994-07-05
K935487	Shimadzu Whole Body X-Ray CT Scanner Sct-4800Tf	Shimadzu Corp.	JAK	Class II	1994-07-05
K934946	Biliblanket Plus Phototherapy System	Boc Health Care, Inc.	LBI	Class II	1994-07-05
K934677	U. S. Medical Ps-3500 Warmer/incubator Scale	U.S. Medical Corp.	FMT	Class II	1994-07-05
K931539	Normed Titanium Miniplate System	Normed Medizin-Technik GmbH	JEY	Class II	1994-07-05
K930552	Sterile Barrier Sleeve and Cover	Patient Safety Products, Inc.	MMP	Class II	1994-07-05
K925115	Amd Dentist and Hygienist Kits	Advance Medical Designs Inc	EKJ	Class I	1994-07-05
K911884	Advance Pressure Monitor/high Pressure Lines	Advance Medical Designs Inc	DTL	Class II	1994-07-05
K942636	Psb Preperitoneal Structure Balloon	Origin Medsystems, Inc.	GCJ	Class II	1994-07-01
K942499	Insulated Surgical Electrode	Springfield Surgical Instruments	GEI	Class II	1994-07-01
K942439	Zeiss Opmilas 144 Surgical Lasers	Zeiss Humphrey System	GEX	Class II	1994-07-01
K942233	Mkm (Multiple Coordinate Manipulator) System	Carl Zeiss, Inc.	EPT	Class I	1994-07-01
K942155	Hmt Endoscreen, Model Esc 501	Servicetrends, Inc.	FCW	Class II	1994-07-01
K941897	Ultracison Harmonic Scalpel Hs2 Blade	Ultracision, Inc.	GEI	Class II	1994-07-01
K941747	Surgistar Trocars	Surgistar, Inc.	GCJ	Class II	1994-07-01
K940793	Double Trach Swivel Connector	Seven Harvest Intl. Import & Export	BZA	Class I	1994-07-01
K940493	Hand Aneroid Sphygmomanometer	Welch Allyn Inc	DXQ	Class II	1994-07-01
K936262	Dissectors, Forceps, Scissors, Dilation Sets, and Gall Stone Collectors	Medicon Instruments, Inc.	GCJ	Class II	1994-07-01
K935609	4002 Infant Scale for Incubators and Warmers	Scale-Tronix, Inc.	FMT	Class II	1994-07-01
K935510	Vx4 Recording Pulse Oximeter	Vitalog Monitoring,Inc.	DQA	Class II	1994-07-01
K935053	Bivona Nasal Turbinate Stent	Bivona Medical Technologies	LYA	Class I	1994-07-01
K932897	Transcutaneous Electrical Nerve Stimulator	Nemectron GmbH	GZJ	Class II	1994-07-01
K932299	Electro-Mesh	Prizm Medical, Inc.	GXY	Class II	1994-07-01
K930624	Sanitas Whirpool Bathing System	Dutton-Lainson Co.	ILJ	Class II	1994-07-01
K930581	E-Z-Flate	E-Z-EM, Inc	FCX	Class II	1994-07-01
K942395	Endotracheal Tube Holder	S.T.I. Medical Products Corp.	CBH	Class I	1994-06-30
K942174	Influenza B Anitgen Test	Neogenex	GNW	Class I	1994-06-30
K942173	Rsv Antigen Test	Neogenex	LKT	Class I	1994-06-30
K942171	Cmv Early Antigen Test	Neogenex	GQI	Class II	1994-06-30
K942039	Sunglasses	Valiente Co.,Ltd.	HQY	Class I	1994-06-30
K941943	Surgical Adhesive Tape	Raleigh Lions Clinic for the Blind, Inc.	KGX	Class I	1994-06-30
K941840	Hemagen Acl Iga Calibrator	Hemagen Diagnostics, Inc.	MID	Class II	1994-06-30
K941509	Radias Ana Screen Enzyme Immunoassay	Bio-Rad	LJM	Class II	1994-06-30
K941312	Sharplan Swiftlase 765/766/767 Flashscan	Sharplan Lasers, Inc.	GEX	Class II	1994-06-30
K941016	Dispens-O-Disc(tm) Nitrocefin	Difco Laboratories, Inc.	JTO	Class I	1994-06-30
K941007	Catalog No. J-Act+ & Qc-Act+	Accriva Diagnostics, Inc.	JBP	Class II	1994-06-30
K940592	Sunglasses	Sunblue Intl., Inc.	HQY	Class I	1994-06-30
K936101	Conmed Versa-Stim Neuromuscular Stimulation Electrode	Conmedcorp	GXY	Class II	1994-06-30
K933827	Biosil Medical Grade Silicone Sheeting for Obstetrical & Gynocology Applications	Bioplexus Corp.	FTL	Class II	1994-06-30
K933340	Osteo Interlocking-Compression Nail	Osteo AG	HSB	Class II	1994-06-30
K932911	Ortholoc Advantim L.s. Tibial Component	Dow Corning Wright	JWH	Class II	1994-06-30
K932054	Vinyl Examination Gloves	Assured Medical Supply Co., Ltd.	LYZ	Class I	1994-06-30
K930954	The Cabot Medical Insul-Sheth Vaginal Speculum Cov	Cabot Medical Corp.	HIB	Class II	1994-06-30
K930224	Stryker Arthroscopic Accessories	Stryker Corp.	GCJ	Class II	1994-06-30
K930096	No Cross Contam Hydrotherapy Tank Liner	Land and Sky Mfg., Inc.	ILJ	Class II	1994-06-30
K924875	Microtrapper/microdigitrapper, Add Modifications	Synectics-Dantec	BZQ	Class II	1994-06-30
K924611	Irrigation Pump and Tubing Set	Marlo Surgical Technology	HET	Class II	1994-06-30
K942748	Intrasite	Smith & Nephew United, Inc.	NAE	Class I	1994-06-29
K941999	Hypertonic Saline Wet Dressing - Sterile	Trinity Laboratories, Inc.	KMF	Class I	1994-06-29
K941972	Hemo-O-Lok	King & Spalding	FZP	Class II	1994-06-29