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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2984 of 3529

510(k) clearances, page 2984 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851671	Gastrointestinal Tube	Sheridan Catheter Corp.	KNT	Class II	1985-06-14
K851479	Vygon Balloon for Identification of Epidural 193	Vygon Corp.	CAZ	Class II	1985-06-14
K851327	Deseret Arterial Catheter	Parke-Davis Co.	FOZ	Class II	1985-06-14
K851193	Anesthesia Breathing Circuit	Avatron, Inc.	CAI	Class I	1985-06-14
K851070	Resp-Bac Bacteria Filter	Medicomp, Inc.	CAH	Class II	1985-06-14
K844563	Phoenix Anesthesia Machine	American Anesthesia, Inc.	BSZ	Class II	1985-06-14
K842349	Ambulatory Ph Recording Device	Clinical Data Instruments, Inc.	DSH	Class II	1985-06-14
K852141	Sterile Surgical Blades	Miltex Instrument Co.	GES	Class I	1985-06-13
K852138	Wescor Stain Pack for Model 7100 Aerospray Slide S	Canyon Diagnostics, Inc.	IAF	Class I	1985-06-13
K852091	Alba Dry Burn Pad	Alba-Waldensian, Inc.	NAD	Class I	1985-06-13
K852070	Shiley Silicone Sual Lumen Subclavian Cannual	Shiley, Inc.	LFJ	Class II	1985-06-13
K851964	E.r.c.p.-1 Endoscopic Retrograde Cholangio-Cathete	Wilson-Cook Medical Inc.	KNS	Class II	1985-06-13
K851956	Vpds-1 Vennes Pancreatic Dilation Set	Wilson-Cook Medical Inc.	FGE	Class II	1985-06-13
K851881	Orthopeadic Cement Delivery System	Dentsply Intl.	KIH	Class I	1985-06-13
K851749	1-380 Pinwheel (Wartenberg)	Artiberia	GWY	Class I	1985-06-13
K851748	1/310, 1-320 Percussion Hammers,taylor, Dejerine	Artiberia	GWZ	Class I	1985-06-13
K851329	Magic Monoclonal Antibody Tsh(mab Tsh)radioimmunoa	Corning Medical & Scientific	JLW	Class II	1985-06-13
K851300	Neuropack 8, Mee-4108	Nihon Kohden America Inc	GWF	Class II	1985-06-13
K851232	Teca Montage II	Teca, Inc.	GWQ	Class II	1985-06-13
K851065	Gravity King (Deemed Se 87/09/18)	Unique Functional Products	ION	Class I	1985-06-13
K850830	Sharp Digital Bp Monitor Mb-371H	Sharp Electronics Corp.	DXN	Class II	1985-06-13
K850778	Set -502T Ph Esophageal Micro Size Electrode	Settler Medical Electronics, Inc.	FFT	Class I	1985-06-13
K850418	Bushel Off-Head Preamplifier	Oxford Medilog, Inc.	GWQ	Class II	1985-06-13
K844594	Neuro Custom Surgical Kit	Xanmed Corp.	HBA	Class II	1985-06-13
K843367	Rotavirus Enzyme Immunoassay	Intl. Diagnostic Laboratories, Ltd.	LIQ	Class I	1985-06-13
K852297	Johnson & Johnson Ostomy Size Selector & Belt	Johnson & Johnson Professionals, Inc.	EXB	Class I	1985-06-12
K852162	Mni 400 Injection Caps	Med-West, Inc.	LFJ	Class II	1985-06-12
K852135	Bsm 21 Blood Safety Module	Hospal Medical Corp.	KOC	Class II	1985-06-12
K852134	Bsm 22 Blood Safety Module	Hospal Medical Corp.	KOC	Class II	1985-06-12
K852112	Surgical Starter Kit	Devon Industries, Inc.			1985-06-12
K851876	Prefer Incontinence Aid	Rocky Mountain Medical Corp.	EYQ	Class I	1985-06-12
K851539	Chesebrough-Ponds Kangaroo Pump Set W/easy-Cap Clo	Chesebrough-Pond'S U.S.A. Co.	KNT	Class II	1985-06-12
K851471	Tribag, Triband & Trifix-Reuseable Urine Collector	Lic-Orthion	KNX	Class II	1985-06-12
K851470	Bibag, Biband & Bifix - Single Use Urine Collector	Lic-Orthion	KNX	Class II	1985-06-12
K851452	Valtrac Pursesting Device	Davis & Geck, Inc.	HCF	Class I	1985-06-12
K851431	Hemodialysis Concentrate Additives	Dana Laboratories	KPO	Class II	1985-06-12
K851362	Standard Solution of Conductivity & Measurement of	Rna Medical Corp.	FKH	Class II	1985-06-12
K851306	Cobe System 3	Cobe Laboratories, Inc.	FKP	Class II	1985-06-12
K851025	Aggro/link Computer Interface	Chrono-Log Corp.	JBX	Class II	1985-06-12
K850877	Monolift Mpe2, Platform, Chair, Fully Futo Platfor	Ketronic, Inc.	ILK	Class II	1985-06-12
K850873	Hilo Tables, Type Ch-4, Ch-8, Fw-6, Fw-5, Fw-2, Al	Ketronic, Inc.	INO	Class II	1985-06-12
K850870	Medifette Ergometer	Ketronic, Inc.			1985-06-12
K850869	Mfe Couch Ergometer	Ketronic, Inc.	ISD	Class II	1985-06-12
K850868	Mfe Cardiac Stress System	Ketronic, Inc.			1985-06-12
K852240	Sms, Screen Machine System	Pandex Laboratories, Inc.	JZT	Class I	1985-06-11
K852207	Oxford Vdt-40 Display Terminal	Oxford Medilog, Inc.	DSI	Class II	1985-06-11
K852042	Brimfield Cannulated Blade Holder	Brimfield Scientific Instruments	GDZ	Class I	1985-06-11
K852039	Flex-Loop Flexible Ear Corette	Bionix, LLC	JYG	Class I	1985-06-11
K852037	Norelco Electronic Digital Blood Pressure Meter	Philips Park	DXN	Class II	1985-06-11
K852011	Nylamid Mesh Pad Full & Half	S. Jackson, Inc.	FTM	Class II	1985-06-11