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 1936 of 3531

510(k) clearances, page 1936 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964250	Linx Networking System	Sterling Diagnostic Imaging, Inc.	LMD	Class I	1996-12-18
K964212	Quinidine Enzyme Immunoassay	Diagnostic Reagents, Inc.	LBZ	Class II	1996-12-18
K964203	Piperacillin/tazobactam 4	Ab Biodisk	JWY	Class II	1996-12-18
K964124	Philips Computed Radiography	Philips North America LLC	LLZ	Class II	1996-12-18
K964072	Monocryl (Poliglecaprone 25) Suture, Undyed	Ethicon, Inc	GAN	Class II	1996-12-18
K963953	Imig-MRI	Imig-Mri Systems, LLC	LNH	Class II	1996-12-18
K963939	Synermed Direct Bilirubin Reagent Kit	Synermed, Inc.	CIG	Class II	1996-12-18
K963896	Mobile CT Prospeed Family	GE Healthcare	JAK	Class II	1996-12-18
K963888	C-Arm Table Ivs-100	Shimadzu Medical Systems	JAA	Class II	1996-12-18
K963861	Lasershare Print Spooler And/or Software	Dejarnette Research Systems	LMD	Class I	1996-12-18
K963859	Qlva Plus	Sanders Data Systems, LLC	LLZ	Class II	1996-12-18
K963826	Endocare Crycare Cryosurgical System	Varian Medical Systems, Inc.	GEH	Class II	1996-12-18
K963807	Tomtec Echo-Scan	TOMTEC Imaging Systems GmbH	IYO	Class II	1996-12-18
K963641	Streptococcus Mic Panel	Dade Microscan, Inc.	JWY	Class II	1996-12-18
K963228	Repliderm Wound Dressing	Orphan Medical, Inc.	KGN	Unclassified	1996-12-18
K962864	Thb Cal Standard for Il Co-Oximeters/oximeters	Alko Diagnostic Corp.	KRZ	Class II	1996-12-18
K962583	Cat Scooter with Ds60 Vonytollrt	Invacare Respiratory Corp.	INI	Class II	1996-12-18
K962049	C-Reactive Protein (Crp) Agglutination Latex Kit	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	DCK	Class II	1996-12-18
K960839	Film Scanner 300	Cannon U.S.A., Inc.	LMA	Class II	1996-12-18
K964554	Personal Telemedicine Module	American Telecare, Inc.	DRG	Class II	1996-12-17
K964316	Plastic Sunglasses	Medical Reports Exchange, Inc.	HQY	Class I	1996-12-17
K964289	Eye Fixation Speculum	Eyefix, Inc.	HNC	Class I	1996-12-17
K963993	Rusch Simplastic Foley Catheterization Set	Rusch, Inc.	FCM	Class II	1996-12-17
K963749	High Pressure Injection Lines	Maxxim Medical	DTL	Class II	1996-12-17
K963307	Gdc Patient Return Electtrode Model 45021	Target Therapeutics	HCG	Class II	1996-12-17
K962894	Synthes High Tibial Osteotomy (Hto) System	Synthes (USA) Products LLC	HRS	Class II	1996-12-17
K962572	Scimed Choice Pt Vision Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1996-12-17
K962538	Bard Coagulating Resector Model (3552Xx; Xx=01,02,03,04,05 or 06)	C.R. Bard Inc	FAS	Class II	1996-12-17
K962185	Hydrasoft (East) and Hydrasoft Toric(east) (Methafilcon B) Daily Wear Soft Hydrophilic Contact Lens	CooperVision, Inc.	LPL	Class II	1996-12-17
K961318	1St Response Disposable Manometer	Intertech Resources, Inc.	CAP	Class II	1996-12-17
K955791	Surgiflator-20 Pim	Novanta Medical GmbH	HIF	Class II	1996-12-17
K954642	Hydro-Select Guidewire	Microvena Corp.	DQX	Class II	1996-12-17
K964835	Coverage Spray HBV	Convatec, A Division of E.R. Squibb & Sons	LRJ	Class I	1996-12-16
K964830	Elecsys Calcheck Lh	Boehringer Mannheim Corp.	JJX	Class I	1996-12-16
K964829	Elecsys Calcheck Fsh	Boehringer Mannheim Corp.	JIX	Class II	1996-12-16
K964713	Solder Gpw	Gateway Alloys, Inc.	EJS	Class II	1996-12-16
K964708	Solder 615	Gateway Alloys, Inc.	EJT	Class II	1996-12-16
K964707	Solder 585	Gateway Alloys, Inc.	EJS	Class II	1996-12-16
K964706	Solder 650	Gateway Alloys, Inc.	EJS	Class II	1996-12-16
K964705	Solder Gpy	Gateway Alloys, Inc.	EJS	Class II	1996-12-16
K964693	Elecsys Fsh Assay	Boehringer Mannheim Corp.	CGJ	Class I	1996-12-16
K964687	N Latex Crp Mono Reagent	Behring Diagnostics, Inc.	DCH	Class II	1996-12-16
K964558	Vitros Immunodiagnostics Products/tsh Reagent Pack (Gem. 1001)/Tsh Calibrators(gem.c001)	Johnson & Johnson Clinical Diagnostics, Inc.	JLW	Class II	1996-12-16
K964345	Ethicon Absorbable Poly (L-Lactide/glycolide) Surgical Suture, Undyed	Ethicon, Inc	GAM	Class II	1996-12-16
K964323	Chromoprint Chromatic Alginate Impression Material	Fen Dental Mfg., Inc.	ELW	Class II	1996-12-16
K964111	Lithovac Suction/aspiration Probe	E.M.S. - Electro Medical Systems SA	KQT	Class II	1996-12-16
K964100	Vision-Sciences Model Ss-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic Sigmoidoscope and Vsi S-V100	Cogentix Medical, Inc.	FAM	Class II	1996-12-16
K964007	Acromed Cable/wire Pedicle Screw	Acromed Corp.	MNH	Class II	1996-12-16
K963973	Depuy Cannulated Cross Pin Screw System	Depuy, Inc.	JDW	Class II	1996-12-16
K963934	Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329	Bio-Rad Laboratories Inc.	MMI	Class II	1996-12-16