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 2201 of 3531

510(k) clearances, page 2201 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940565	Coe-Soft Lc	GC America Inc.	EBI	Class II	1994-05-04
K940521	Mill-Rose Protected Translaryngoscopic Catheter	Mill-Rose Laboratory	EOQ	Class II	1994-05-04
K940508	Ophta Sil (Ritleng Probe and Lacrimal Intubation Set)	G.W.B. Intl., Ltd.	OKS	Unclassified	1994-05-04
K940404	Alginate Fiber Topical Wound Dressing	Adri	KMF	Class I	1994-05-04
K940394	Amg Med Brand Clinical Glass Thermometer	Technolab Industries (Canada), Ltd.	FLK	Class II	1994-05-04
K940380	Amg Med Brand Clinical Glass Thermometer	Amg Medical Inc.	FLK	Class II	1994-05-04
K936196	Antithrombin III Chromogenic Assay	Baxter Diagnostics, Inc.	JBQ	Class II	1994-05-04
K936161	System, X-Ray, Mamographic	Technowipe	IZH	Class II	1994-05-04
K935962	Miracle-Ear with Power Circuit Option	Miracle-Ear, Inc.	ESD	Class I	1994-05-04
K935738	Medtronic Gciii Coronary Guiding Catheter	Medtronics Interventional Vascular	DQY	Class II	1994-05-04
K934614	Mini Fragment Plate	Onyx Medical LLC	HRS	Class II	1994-05-04
K934011	Mityvac(r) Obstetric Vac Deliv Kit W/univ Vac Release	Neward Enterprises, Inc.	HDB	Class II	1994-05-04
K933741	Carrasyn Oral Wound Dressing	Carrington Laboratories, Inc.	OLR	Unclassified	1994-05-04
K933205	Tsrh(r) Top Tight T-Bolt-Vari Angle/screw/paragon	Danek Medical, Inc.	KWP	Class II	1994-05-04
K932202	Model 3862A & B 3863A & B Temp. Lead Screening Kit	Medtronic, Inc.	GZB	Class II	1994-05-04
K931692	T-Plate	Onyx Medical LLC	HRS	Class II	1994-05-04
K931684	Epiphysis Plate	Onyx Medical LLC	HRS	Class II	1994-05-04
K931680	Cannulated Cancellous Screw	Onyx Medical LLC	HWC	Class II	1994-05-04
K931538	Amset(tm) Cannulated Bone Screw	Advanced Med/Surg, Inc.	HWC	Class II	1994-05-04
K930132	Leep and Lletz Electrodes	Nordex Medical Corp.	HGI	Class II	1994-05-04
K926298	520 Display Driver- Status I	Vidco, Inc.	DRT	Class II	1994-05-04
K925738	White River Manual Breast Pump	White River (Tm)	HGY	Class I	1994-05-04
K941813	Venshield	Cybermedic, Inc.	BYD	Class I	1994-05-03
K941377	Conquest Smooth Touch	Jeneric/Pentron, Inc.	EBF	Class II	1994-05-03
K941373	Pent Core Plus (Paste-Paste)	Jeneric/Pentron, Inc.	EBF	Class II	1994-05-03
K941287	Liquid Alt(sgpt) Reagent Set	Horiba Instruments Incorporated	CKA	Class I	1994-05-03
K941091	Synermed Amylase Reagent Kit	Synermed, Inc.	JFJ	Class II	1994-05-03
K940934	Life Vac	Life Support Products, Inc.	BTA	Class II	1994-05-03
K940875	Adjustable Balloon Dissection Cannula	Origin Medsystems, Inc.	GCJ	Class II	1994-05-03
K940721	Clinix Vp 4 Table	Philips North America LLC	IXR	Class II	1994-05-03
K940559	Acs Powerbase(tm) Coronary Guiding Catheter	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1994-05-03
K940390	Impact	Matrix Technologies Corp.	JQW	Class I	1994-05-03
K940267	Ace Clinical Chemistry System	Schiapparelli Biosystems, Inc.	KXT	Class II	1994-05-03
K940251	Mitochondria Eia Test Kit	David A. Fuccillo, Ph.D.	DBM	Class II	1994-05-03
K940236	Quantitative Heart	Siemens Medical Solutions USA, Inc.	KPS	Class II	1994-05-03
K940123	Methaqualone Enzyme Immunoassay	Diagnostic Reagents, Inc.	KXS	Class II	1994-05-03
K940116	Completely in the Canal	Argosy Electronics	ESD	Class I	1994-05-03
K940096	Ps Medical Catheter Placement Kit	Pudenz-Schulte Medical Research Corp.	GWG	Class II	1994-05-03
K935861	Mednext Bur	Mednext, Inc.	HBE	Class II	1994-05-03
K935404	Flow Directed Thermodilution Balloon Catheter	J-Lloyd Medical, Inc.	DYG	Class II	1994-05-03
K934169	Foundation All Poly Cup	Encore Orthopedics, Inc.	JDI	Class II	1994-05-03
K932923	Implex a-230 Porous Acetabular Cup Syst.cementless	Implex Corp.	LPH	Class II	1994-05-03
K932834	Tecnol Pcm 2000	Tecnol Medical Products, Inc.	FXX	Class II	1994-05-03
K932687	Ame(r) Universial Cable System	American Medical Electronics, Inc.	JDQ	Class II	1994-05-03
K930842	The Grieshaber Syst/ai Tubing Set and Cartridge	Grieshaber & Co.	HQE	Class II	1994-05-03
K925168	Miscellaneous Pacing Lead	Oscor Medical Corp.	DTD	Class II	1994-05-03
K915403	Diagnostic Ultrasound System	FUJIFILM Healthcare Americas Corporation	IYN	Class II	1994-05-03
K913013	Tcpo2 9260 Module - System Athena	S & W Medico Teknik	LKD	Class II	1994-05-03
K941378	Procom	Jeneric/Pentron, Inc.	EBF	Class II	1994-05-02
K941376	Conquest Senior	Jeneric/Pentron, Inc.	EBF	Class II	1994-05-02