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 2207 of 3531

510(k) clearances, page 2207 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941585	Hygroster	Mallinckrodt Medical	BYD	Class I	1994-04-19
K941549	Biopsy Needle and Housing	Biopsys Medical, Inc.	KNW	Class II	1994-04-19
K941536	Barrierbac and Barrierbac S	Mallinckrodt Medical	CAH	Class II	1994-04-19
K941500	Tissue Isolation and Retrieval Bag	Advanced Surgical, Inc.	GCJ	Class II	1994-04-19
K941384	Trakeez	Ergomed, Inc.	CBH	Class I	1994-04-19
K941283	Innersense Disposable Microtransducer	Becton Dickinson Vascular Access, Inc.	DXO	Class II	1994-04-19
K941213	Songer Cable System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	1994-04-19
K941196	Platex Tampons Model Number 07094	Playtex Family Products, Inc.	HIL	Class II	1994-04-19
K941160	Conmed T.d.s. Electrosurgical Ground Pad	Conmedcorp	GEI	Class II	1994-04-19
K940936	Aesculap Endoscopic Instruments	Aesculap Inc	GEI	Class II	1994-04-19
K940888	System 22 Paediatric Mask	Medic-Aid, Ltd.	BYG	Class I	1994-04-19
K940887	System 22 Adult Mask	Medic-Aid, Ltd.	BYG	Class I	1994-04-19
K940603	Scimed 8 French Triguide Guiding Catheter	Scimed Life Systems, Inc.	DQY	Class II	1994-04-19
K940544	Double Trach Seivel Connector	Fvtnks	BZA	Class I	1994-04-19
K940496	Prophy Paste	Challenge Products, Inc.	EJR	Class I	1994-04-19
K940484	Coroskop Hi-P Angiographic X-Ray System	Siemens Medical Solutions USA, Inc.	IZI	Class II	1994-04-19
K940250	New Eyes Eyeglass Frame	Sunrise International Business	HQY	Class I	1994-04-19
K940192	Mis Electrosurgical Electrodes	National Wire & Stamping, Inc.	GEI	Class II	1994-04-19
K935952	Rota System 5000	Rota Systems Medfurniture, Inc.	HMF	Class I	1994-04-19
K935945	Rota Datamate I	Rota Systems,Inc.	HMF	Class I	1994-04-19
K935943	King's Sunglass Corp.	King'S Sunglass Corp.	HQY	Class I	1994-04-19
K935467	R & D Batteries, Inc. Part Number 5447	R & D Batteries, Inc.	BXB	Class I	1994-04-19
K935244	R & D Batteries, Inc. Part Number 5113	R & D Batteries, Inc.	ILQ	Class II	1994-04-19
K934844	Inter Tip T	MicroSurgical Technology Inc	HMX	Class I	1994-04-19
K934326	Multifibren U	Behring Diagnostics, Inc.	KQJ	Class II	1994-04-19
K934266	Comfort Cath Self Adhering Male External Catheter	Sierra Laboratories, Inc.	EXJ	Class I	1994-04-19
K933793	Ground/reference Needle Electrode	Cadwell Laboratories, Inc.	GXZ	Class II	1994-04-19
K933211	D'amico\peyman Fluted Endoprobe	Iriderm Div.	GEX	Class II	1994-04-19
K933203	Apollo(tm) Hip Syst-Straight Stem/all-Poly Acet Comp	Intermedics Orthopedics	LZO	Class II	1994-04-19
K933169	Inman Endoscopic Blunt Dissector	Inman Medical Corp.	GCJ	Class II	1994-04-19
K933125	Berichrom Antithrombin III (a)	Behring Diagnostics, Inc.	JPE	Class II	1994-04-19
K932216	C-Section, Labor & Delivery Trays (Packs)	Associated Medical Products Co.	MLS	Class II	1994-04-19
K931630	Insemi-Cath	Cook Ob/Gyn	MFD	Class II	1994-04-19
K931571	Link Ceramic Heads 12/14 X 32Mm	Link America, Inc.	LZO	Class II	1994-04-19
K930696	Sure-Flo Insufflation Tubing	O.R. Resources, Inc.	HIF	Class II	1994-04-19
K926292	Babylog 8000 Infant Ventilator	Drager, Inc.	CBK	Class II	1994-04-19
K920790	Marquette Eagle Monitor	Marquette Electronics, Inc.	DSI	Class II	1994-04-19
K941012	Low Pressure Tamponade Balloon Catheter	Applied Medical Resources Corp	EYB	Class II	1994-04-18
K941010	Acucise Guidewire Exchange Sheath	Applied Medical Resources Corp	EYB	Class II	1994-04-18
K940542	Namic Aria(tm) Inflation Device	American Medical Systems, Inc.	EZN	Class II	1994-04-18
K940232	Innerdyne Step Trocar Expandable Port, S.t.e.p.	Innerdyne Medical, Inc.	GCJ	Class II	1994-04-18
K936041	Urogram Cystometrogram	Myo/Kinetic Systems, Inc.	FEN	Class II	1994-04-18
K935495	Pf404/409/410/411/416/418 W/pf319:0/319:1/319:2	Perimed AB	GEX	Class II	1994-04-18
K935273	Vision Fx 40 & 80 Series Gamma Camera	Summit Nuclear	IYX	Class I	1994-04-18
K933094	Insufflator Tubing Kit W/filter	Inman Medical Corp.	HIF	Class II	1994-04-18
K930767	Insufo-Gard #100-104	Acorn Medical, Inc.	HIF	Class II	1994-04-18
K926385	Bard Apii Pump	C.R. Bard Inc	FRN	Class II	1994-04-18
K941535	Tracheolife	Mallinckrodt Medical	BYD	Class I	1994-04-15
K941448	Retractor	Technovations	GAD	Class I	1994-04-15
K941381	Hygrobac,s Hygroboy and Hygrobaby	Mallinckrodt Medical	CAH	Class II	1994-04-15