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 2317 of 3531

510(k) clearances, page 2317 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924802	Calibration Verification Kit or Cvk	Radiometer America, Inc	JJY	Class I	1993-03-09
K923076	Ultra Sx	Excel Tech., Ltd.	IMI	Class II	1993-03-09
K923045	Sensititre Susceptibility Plates	Radiometer America, Inc	JWY	Class II	1993-03-09
K922753	Compel Xtr	Standard Textile Co., Inc.	FYA	Class II	1993-03-09
K922416	Fibrinogen Rid Test Kit	The Binding Site	KQJ	Class II	1993-03-09
K921952	Ultra III	Excel Tech., Ltd.	IMG	Class II	1993-03-09
K921190	Adap-Temp Temperature Sensor Adapter	Respiratory Support Products, Inc.	FLL	Class II	1993-03-09
K920983	Sonopuls 590	Henley Intl.	IMI	Class II	1993-03-09
K925443	Incudostapedial Joint	Smith & Nephew Richards, Inc.	ETB	Class II	1993-03-08
K923816	Contact Lens Cleaning Accessory	Cramer Ent., Inc.	LYL	Class II	1993-03-08
K923603	Intra-Aortic Balloon Pump Catheter - Modification	Kontron Instruments, Inc.	DYB	Class II	1993-03-08
K923221	King of Hearts Scepter	Instromedix, Inc.	DPS	Class II	1993-03-08
K922946	Vaportemp Heat and Moisture Exchanger	Mallinckrodt Medical	BYD	Class I	1993-03-08
K922781	Flow Conrol Valve	American Omni Medical, Inc.	MJJ	Class II	1993-03-08
K926344	Hydrophilic Coated Guidewire	Surgitek	KNY	Class II	1993-03-05
K926225	Sponge Counter	American Medical Manufacturer, Inc.	FWZ	Class I	1993-03-05
K925846	Immulite Prolactin	Siemens Healthcare Diagnostics Inc.	CFT	Class I	1993-03-05
K924827	Microdose Potassium Oxylate	Unicep	LBH	Class II	1993-03-05
K924826	Microdose Total Etchant	Unicep	EBF	Class II	1993-03-05
K924825	Microdose Rc-Ez	Unicep	EKM	Class I	1993-03-05
K924822	Microdose Enamel Etchant	Unicep	EBF	Class II	1993-03-05
K924666	Intelect Ifc2	Chattanooga Group, Inc.	LIH	Class II	1993-03-05
K923722	Hn-40	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-05
K923721	Prospector	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-05
K923720	Suncast	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-05
K923719	Suncast D-Kf	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-05
K923718	Hp-3	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-05
K923716	Jel-0-75	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-05
K923715	Suncast-D	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-05
K923444	Servo Graphics	Siemens Medical Solutions USA, Inc.	CBK	Class II	1993-03-05
K923436	Illuminated Ureteral Catheter	Cook Incorporated	FCS	Class II	1993-03-05
K923232	Endodontic Post W/ Accessories	Veillette Ent.	ELR	Class I	1993-03-05
K922438	Pro2 Oxygen Analyzer	Martech Medical Products	CCL	Class II	1993-03-05
K914790	Hollow Fiber Dialyzer Focus 9Or/90h-R/120r/120h-R	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1993-03-05
K914126	Vmx Mini-Log Flowmeter	Clement Clarke, Inc.	BZH	Class II	1993-03-05
K930185	Ovusign Lh/conception Plus/ovudate Lh One-Step	Princeton Biomedix	CEP	Class I	1993-03-04
K926562	Quanta Lite(tm) Jo-1 Elisa Kit	Inova Diagnostics, Inc.	LLL	Class II	1993-03-04
K926404	Kodak X-Omatic Identification Camera, Model 4 & 4L	Eastman Kodak Company	JAC	Class I	1993-03-04
K926336	Audioscan	Electrocaine Medical System	EWO	Class II	1993-03-04
K926304	Bactec Peds Plus/f	BD Becton Dickinson Vacutainer Systems Preanalytic	MDB	Class I	1993-03-04
K925995	Arthrex Instruments (Knee, Gp 3)	Arthrex GmbH	HRX	Class II	1993-03-04
K925986	Arthroscopic Acl Drill System	Arthrex GmbH	HRX	Class II	1993-03-04
K925954	Arthrex Instruments (Basic)	Arthrex GmbH	HRX	Class II	1993-03-04
K925934	Wall Bucky Holders Lt. & Rt. Hand, & Center Mount	Continental X-Ray Corp.	IXY	Class I	1993-03-04
K925884	Arthroscopic Retractors and Graspers	Arthrex GmbH	HRX	Class II	1993-03-04
K925814	Arthrex Instruments (Basic)	Arthrex GmbH	HRX	Class II	1993-03-04
K925544	Seidel Humeral Locking Nail & Additional Lengths	Howmedica Corp.	HSB	Class II	1993-03-04
K925458	Arthrex Ring Curette	Arthrex GmbH	HRX	Class II	1993-03-04
K925457	Arthrex Bayonet Knife	Arthrex GmbH	HRX	Class II	1993-03-04
K925456	Arthroscopic Instruments	Arthrex GmbH	HRX	Class II	1993-03-04