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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3461 of 3526

510(k) clearances, page 3461 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K772381	Ring Handle & Retractors	Edward Weck, Inc.	KAL	Class I	1978-01-17
K772380	Farrior Oval Speculum	Edward Weck, Inc.	EPY	Class I	1978-01-17
K772377	Hildyard Post Nasal Forcep	Edward Weck, Inc.	KAE	Class I	1978-01-17
K772372	Roller Knife	Edward Weck, Inc.	JYO	Class I	1978-01-17
K772370	Barraquer Oval Speculum-Various Sizes	Edward Weck, Inc.	EPY	Class I	1978-01-17
K772357	Pulse Generators	Medtronic, Inc.	DXY	Class III	1978-01-17
K772351	Dental Light	Chemetron Dental Products	EAZ	Class I	1978-01-17
K772296	Inspiron Manifold	C.R. Bard Inc	CAF	Class II	1978-01-17
K772295	Inspiron Manifold (Single)	C.R. Bard Inc	CAF	Class II	1978-01-17
K772294	Inspiron Manifold (Double)	C.R. Bard Inc	CAF	Class II	1978-01-17
K772287	Muscle Stimulator	Rich-Mar Corp.	IMG	Class II	1978-01-13
K771817	Emi Therapy Simulator	Emi Therapy Systems, Inc.	JAD	Class II	1978-01-13
K772360	Arrhythmia Module	General Electric Co.	DSI	Class II	1978-01-12
K772337	Urinary 17-Ketosteriod/17	Eppendorf-Brinkmann, Inc.	CDG	Class I	1978-01-12
K772330	T4 Ria Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	CDX	Class II	1978-01-12
K772325	Densitometer 18, Computing, Auto.	Gelman Instrument Co.	JQT	Class I	1978-01-12
K772319	Analyzer, Clinical, System 3	Gilford Instrument Laboratories, Inc.	JJE	Class I	1978-01-12
K772311	Wisp Model 710	Waters Assoc., Inc.	CHH	Class I	1978-01-12
K772192	Neonatal Tsh Ria Kit (125I)	Siemens Healthcare Diagnostics Inc.	JLW	Class II	1978-01-12
K772191	Testosterone Ria Kit (125I)	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	1978-01-12
K772038	Kanamycin Ria	Monitor Science Corp.	KJI	Class II	1978-01-12
K771974	Solvenex I-0	Den-Mat Corp.	KZP	Class II	1978-01-12
K771016	Intermedullary Brush	Howmedica Corp.	HTR	Class I	1978-01-12
K770999	Litton 300L Ultrasound System	Electra-Physics Laboratories, Inc.	IYO	Class II	1978-01-12
K772367	Chest Bellows, Small	Honeywell, Inc.	CCM	Class II	1978-01-11
K772347	Phonic Mirror Handivoice Model 120	Hc Electronics			1978-01-11
K772346	Phonic Mirror Handivocie Model 110	Hc Electronics			1978-01-11
K772331	Resteril. of Implant. Elect. & Adapter	Telectronics, Inc.	DTB	Class III	1978-01-11
K772317	Ct/t System Model B7800a	General Electric Co.	JAK	Class II	1978-01-11
K772203	Ventricular Leads	Medtronic, Inc.	DTB	Class III	1978-01-11
K772143	Generator	Electric Field Technology Corp.			1978-01-10
K772305	Rad. Therapy Planning Sup. Sys.	Ohio Nuclear, Inc.	JAK	Class II	1978-01-09
K772406	Aesthesiometer	Fred Sammons, Inc.	GXB	Class I	1978-01-06
K772389	Dandy Hemostatic Forceps	Edward Weck, Inc.	HAO	Class I	1978-01-06
K772371	Bayonet Surgical Instruments	Edward Weck, Inc.	HAO	Class I	1978-01-06
K772353	EKG Acquisition & Analysis Cart	Intl. Business Machines	LOS		1978-01-06
K772285	Aca Lipase Verifiers	E.I. Dupont de Nemours & Co., Inc.	JJX	Class I	1978-01-06
K772281	Rsl Insulin Kit	Radioassay Systems Laboratories, Inc.	CFP	Class I	1978-01-06
K772194	Immo Phase Ft4 Assay	Corning Medical & Scientific	CEC	Class II	1978-01-06
K761138	Fa Tissue Fixative & Wash Set	Zeus Scientific LLC	LDZ	Class I	1978-01-06
K772425	Rianen Gentamicin Ria Kit	New England Nuclear	DJB	Class II	1978-01-05
K772421	Wheelchair Belt	Fred Sammons, Inc.	IQB	Class I	1978-01-05
K772420	Rear Fastening Safety Strap	Fred Sammons, Inc.	IQB	Class I	1978-01-05
K772417	Sliding Board	Fred Sammons, Inc.	IKX	Class I	1978-01-05
K772416	Pre-Formed Splint Blanks	Fred Sammons, Inc.	ILH	Class I	1978-01-05
K772415	Dynameter 50 Lb.	Fred Sammons, Inc.	HRW	Class I	1978-01-05
K772413	Pinch Guage	Fred Sammons, Inc.	HRW	Class I	1978-01-05
K772411	Platform Splints	Fred Sammons, Inc.	ILH	Class I	1978-01-05
K772410	Resting Pan Splints	Fred Sammons, Inc.	ILH	Class I	1978-01-05
K772401	Lap Board W/rim	Fred Sammons, Inc.	IMX	Class I	1978-01-05