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 2045 of 3531

510(k) clearances, page 2045 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951603	Cardima, Inc. Forerunner	Cardima, Inc.	DQY	Class II	1995-10-05
K950755	Flexmate K500	Breg, Inc.	BXB	Class I	1995-10-05
K950398	Catheter, Balloon Type	Interventional Therapeutics Corp.	DQO	Class II	1995-10-05
K950172	Wako Autokit Glucose	FUJIFILM Healthcare Americas Corporation	CGA	Class II	1995-10-05
K945856	Positive Lupus Anticoagulant Plasma	George King Bio-Medical, Inc.	GGC	Class II	1995-10-05
K945853	Thermotek H-300	Thermotek, Inc.	ILO	Class II	1995-10-05
K945734	W&h Roto Quick Couplings	A-dec, Inc.	EFB	Class I	1995-10-05
K944995	Iolab/site Peristaltic Module	Chiron Vision Corp.	HQC	Class II	1995-10-05
K944719	W&h 100 Series Low Speed	A-dec, Inc.	EFB	Class I	1995-10-05
K944718	W&h 900 Incolight Lt Handpiece	A-dec, Inc.	EFB	Class I	1995-10-05
K953613	Imperva Ensurabond	Shofu Dental Corp.	KLE	Class II	1995-10-04
K953612	Imperva Fluorobond	Shofu Dental Corp.	KLE	Class II	1995-10-04
K953532	Ebice	Electro-Biology, Inc.	ILO	Class II	1995-10-04
K953436	Strato/infusaid Infuse-a-Cath Single Lumen Silicone Central Venous Catheter Systesm	Strato/Infusaid, Inc.	LJS	Class II	1995-10-04
K953256	Strato/infusaid Infus-a-Cath Dual Lumen Preattached Silicone Central Venous Catheter Systems	Strato/Infusaid, Inc.	LJS	Class II	1995-10-04
K953159	Erbotom Icc Bipolar	Erbe USA Inc	GEI	Class II	1995-10-04
K952201	Port-a-Cath Access Kit	Medi-Flex Hospital Products, Inc.	FMF	Class II	1995-10-04
K952072	Zomed Model 500 Electrosurgical Generator Model 200 Electrosurgical Probe	Zomed Intl.	GEI	Class II	1995-10-04
K951916	Cc Rider, Model Me180	Mettler Electronics Corp	IKK	Class II	1995-10-04
K951646	3Dsee	Intl. Telepresence Corp.	GCJ	Class II	1995-10-04
K951371	1481 T Digital Telemetry System with S-T Segment Analysis Option	Siemens Medical Solutions USA, Inc.	DSI	Class II	1995-10-04
K950151	Chemmate(tm) L26 (Cd20)	Biotek Solutions, Inc.	DEH	Class II	1995-10-04
K946311	Integral VII 3.25Mm Biointegrated Dental Implant System	Calcitek, Inc.	DZE	Class II	1995-10-04
K954173	Spectacle Sun Glasses (Non Prescription)	Monte Carlo Eyewear, Inc.	HQY	Class I	1995-10-03
K953979	Apolipoprotein Calibrator (Apo-Cal)	Beckman Instruments, Inc.	JIX	Class II	1995-10-03
K953830	Kensorb	Kentron Health Care, Inc.	GDY	Class I	1995-10-03
K953656	Abbott Imx Prolactin(modification)	Abbott Mfg., Inc.	CFT	Class I	1995-10-03
K953581	First Response Ovulation Predictor Test	Armkel, LLC	CEP	Class I	1995-10-03
K953504	Microprime	Danville Engineering, Inc.	KLE	Class II	1995-10-03
K953435	Branemark Radiographic Depth Guage	Nobelpharma USA, Inc.	DZE	Class II	1995-10-03
K953416	Bryan Posterior Spinal Fixator (Bpsf)	Arcan Orthopaedic Corp.	MNH	Class II	1995-10-03
K953173	Nonpowered Neurosurgical Instrument	United States Surgical, A Division of Tyco Healthc	GWG	Class II	1995-10-03
K952834	Shrouded Plastic Cannula	Medical Associates Network, Inc.	FMI	Class II	1995-10-03
K952737	Calvitron Hair Transplant System	Medicamat S.A.	GAH	Class I	1995-10-03
K952553	Alpha Medica Disposable, Sterile, Nonpyrogenic Syringe	Alpha Medica	FMF	Class II	1995-10-03
K952437	Dma Glucose Hexokinase u.v. Procedure	Data Medical Associates, Inc.	CFR	Class II	1995-10-03
K952239	Auto Suture* Modified Linear Stapler**	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1995-10-03
K952047	Lmt 40 Aa Laser Surgical System	Laser Max Medical Technologies Corp.	GEX	Class II	1995-10-03
K952046	Lmt 20 Aa Laser Surgical System	Laser Max Medical Technologies Corp.	GEX	Class II	1995-10-03
K952045	Lmt 20 Hh Laser Surgival System	Laser Max Medical Technologies Corp.	GEX	Class II	1995-10-03
K951705	Ministrip Hcg	International Newtech Development, Inc.	JHI	Class II	1995-10-03
K950996	Dornier Thermafocus 360 Fiber	Daimler-Benz Aerospace	GEX	Class II	1995-10-03
K950821	Hp M1205a Omnicare Component Transport Monitoring System Model 24	Hewlett-Packard Co.	DSI	Class II	1995-10-03
K946179	Siemens Sonoline 4Xx	Siemens Medical Solutions USA, Inc.	IYO	Class II	1995-10-03
K954278	Beta Multi-Procedure Mobile Urological Table, Model S5005	Beta Medical Products Co.	MMZ	Class II	1995-10-02
K954128	Snoremaster	D.D.S., Inc.	LRK	Class II	1995-10-02
K953812	Gauze Sponge	Remington Medical	KHR	Class I	1995-10-02
K953743	Palasplint	Kulzer GmbH	EBI	Class II	1995-10-02
K953678	Sterimed Sterization Wrapper (Non-Sterile)	Customed, Inc	FRG	Class II	1995-10-02
K953605	Ultra-Sensitive Estradiol	Diagnostic Systems Laboratories, Inc.	CHP	Class I	1995-10-02