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 3427 of 3526

510(k) clearances, page 3427 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781817	Ovu-Guide	Reproduction Research Laboratories	FLK	Class II	1978-12-04
K781783	Blood Sugar	Gilford Diagnostics	LFR	Class II	1978-12-04
K781769	Iron 59 Kit	Ria Products, Inc.	JJA	Class I	1978-12-04
K781764	Pad, Cooling #27-999	Cobe Laboratories, Inc.	DTR	Class II	1978-12-04
K781758	Seracon-Srii	Bhp Diagnostix, Inc.	JIX	Class II	1978-12-04
K781757	Seracon-Sri	Bhp Diagnostix, Inc.	JIX	Class II	1978-12-04
K781749	Tubing, Axiom Silicone Penrose	Axiom Medical, Inc.	KDH	Class II	1978-12-04
K781742	Inhamatic 33	Medimatic S.r.l.	IZD	Class I	1978-12-04
K781727	Change in Sterilization Procedure	Absorbent Cotton Co., Inc.	GOY	Class I	1978-12-04
K781715	Ruler, Weck Scott	Edward Weck, Inc.	HOE	Class I	1978-12-04
K781701	Blood Pressure, Digital Model #2153	Sears, Roebuck & Co.	DSK	Class II	1978-12-04
K781694	Pen, Mark-3 Skin Marking Fountain	Omega Mark-3 Pen Corp.	FZZ	Class I	1978-12-04
K781687	Aurofil	Wallace A. Erickson & Co.	EBF	Class II	1978-12-04
K781675	X-Ray Collimator	General X-Ray, Inc.	EHB	Class I	1978-12-04
K781630	Ge-700 Intra Oral X-Ray System	General Electric Co.	EAP	Class II	1978-12-04
K781594	Dental Warm Water Irrigating System	Rama Corp.	ECB	Class I	1978-12-04
K781592	Surgical Aspirator Tips	Henry Schein, Inc.	DYN	Class I	1978-12-04
K781575	Disposable Lymphangiogram Set	Instranetics, Inc.	FPA	Class II	1978-12-04
K781546	Direct Estriol Ria Kit	Immunalysis Corporation	CGI	Class I	1978-12-04
K781456	Endocardial Bipolar Lead	American Technology, Inc.	DTB	Class III	1978-12-04
K781377	Ovalith 10Bp	Coratomic, Inc.	DXY	Class III	1978-12-04
K781351	Auro-Brush	Parker Laboratories, Inc.			1978-12-04
K781326	Unipoplar Endocardial Leads	American Technology, Inc.	DTB	Class III	1978-12-04
K781269	Elisa Systme	Gilford Instrument Laboratories, Inc.	JJQ	Class I	1978-12-04
K781002	Temporary Cardiac Pacing Wire	Ethicon, Inc	LDF	Class II	1978-12-04
K781000	Phosphorus (Inorganic) Analysis Products	Abbott Medical	CEO	Class I	1978-12-04
K781743	Response System, Tn-3000	Tracor Instruments, Inc.	GWL	Class II	1978-12-01
K781741	Mask, Bi Flo Nasal Oxygen	Inhal-O-Tech Medical Plastic	BYG	Class I	1978-12-01
K781704	Stimulator, Tn-3001 Somatosensory	Tracor Instruments, Inc.	GWF	Class II	1978-12-01
K781523	Pft Gases	Gardner Cryogenics	BXY	Class I	1978-12-01
K781911	ECG Analyzer, High Speed	Cardio-Dynamics Laboratories, Inc.	DSI	Class II	1978-11-30
K780775	Medical Protein Hydrolysate Revital	Robertson Resources, Inc.	KOZ	Class I	1978-11-30
K781954	Catheter Introducers, Arterise	C.R. Bard Inc	DYB	Class II	1978-11-29
K781940	EKG Electrodes, Disposable	Hayes Products, Inc.	DRX	Class II	1978-11-29
K781932	Blood Pressure Recorder	Cardiodyne, Inc.	DXN	Class II	1978-11-29
K781808	Slick Set, Cuffed	Polamedco, Inc.	BTR	Class II	1978-11-29
K781692	Calibrator, Dynamic	Waters Assoc., Inc.	DXM	Class II	1978-11-29
K781908	Breathing Circuit Products, Anesthesia	Hospitak, Inc.	CAI	Class I	1978-11-27
K781872	Clinac 2500	Varian Assoc., Inc.	IYE	Class II	1978-11-27
K781759	Rescal	Diemolding Corp.	BZA	Class I	1978-11-27
K781739	Camera, Gca-10A, Low Energy	Toshiba Medical Systems	IYX	Class I	1978-11-27
K781714	Pneumogard Model 1230	Novametrix Medical Systems, Inc.	CAP	Class II	1978-11-27
K781571	L/u Arm-Vascular	General Electric Co.	IYB	Class I	1978-11-27
K780340	Imv System	Lkb Instruments, Inc.	CBD	Class II	1978-11-27
K781925	Pouches, Gas Sterilization	Medicare Industries, Inc.	FRG	Class II	1978-11-22
K781924	Pouches and Tubing, Medi-Seal	Medicare Industries, Inc.	FRG	Class II	1978-11-22
K781907	Ear Stopples for Noise Attention	Crown Delta Corp.	EWD	Unclassified	1978-11-22
K781889	Collins Pedalmate 2	Warren E. Collins, Inc.	ISD	Class II	1978-11-22
K781869	Dropper, Cepti-Seal Koh Solution	Marion Laboratories, Inc.	KEQ	Class I	1978-11-22
K781868	Dropper, Cepti-Seal Lavtophenol	Marion Laboratories, Inc.	KEQ	Class I	1978-11-22