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 2026-11-02, 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 2431 of 3531

510(k) clearances, page 2431 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K913055	Thyroid Uptake Syst/automlab 900 Medi Spec 187-900	Atomic Products Corp.	IZD	Class I	1991-09-06
K913037	Sharplan Sharplase Family Nd:yag Sculpted Fibers	Sharplan Lasers, Inc.	GEX	Class II	1991-09-06
K913036	Plume Master	Sorex Medical	FYD	Class II	1991-09-06
K912965	Api Uniscept Kb	Analytab Products, Inc.	JWY	Class II	1991-09-06
K912949	Triangular Bandage,40	Cal West Trading Co.	NAB	Class I	1991-09-06
K912936	May Humerus Plates	Turnkey Intergration USA, Inc.	HRS	Class II	1991-09-06
K912881	Ge Mr Max	GE Healthcare	LNH	Class II	1991-09-06
K912855	Hazel	KCI USA, Inc.	IOQ	Class II	1991-09-06
K912752	Philips Tomoscan Sr	Philips North America LLC	JAK	Class II	1991-09-06
K912718	Enzyme Linearity Control	Phoenix Diagnostics, Inc.	JJY	Class I	1991-09-06
K912659	Sound Relief	Windmere Corp.	IRO	Class I	1991-09-06
K912597	Electrosurgical Electrode	Megadyne Medical Products, Inc	GEI	Class II	1991-09-06
K912595	Axiom Electromyograph	The Computerist, Inc.	HCC	Class II	1991-09-06
K912591	Avi Micro 210D Infusion Pump	3M Avi, Inc.	FRN	Class II	1991-09-06
K912538	Ktp/yag Plus	Laserscope	GEX	Class II	1991-09-06
K912512	Taichi Stick Massager	Focus International, Inc.	LYG	Class I	1991-09-06
K912503	Hypoallergenic Examination Latex Gloves	Medigloves, Ltd.	LYY	Class I	1991-09-06
K912323	The Remote	Remote Technologies, Inc.	IZL	Class II	1991-09-06
K912182	Meditron Combination Generator Cg-2000	Medical Devices Inc.	GEI	Class II	1991-09-06
K912177	Visionpro	Trionix Research Laboratory, Inc.	KPS	Class II	1991-09-06
K912176	Acqupro	Trionix Research Laboratory, Inc.	KPS	Class II	1991-09-06
K912157	Hypoallergenic Surgical Latex Gloves	Medigloves, Ltd.	KGO	Class I	1991-09-06
K912156	Schneider Magnum Peripheral Recanal Guidewire	Schneider Intl., Ltd.	DQX	Class II	1991-09-06
K911957	Acs Rx Support Catheter	Advanced Cardiovascular Systems, Inc.	DQO	Class II	1991-09-06
K911551	Shower Mini Rd-7 Sanitary Washer	Aiex USA, Ltd.	ILJ	Class II	1991-09-06
K911550	2Nd Skin Moist Burn Pads with Aloe	Spenco Medical Corp.	MGQ	Unclassified	1991-09-06
K911319	Tsrh Open Head Bone Screw	Danek Medical, Inc.	KWP	Class II	1991-09-06
K911282	Pulpdent Enamel Bonding Agent	Pulpdent Corporation	KLE	Class II	1991-09-06
K911128	Mediziv Infusion Set	Medicia Medical Products	FPA	Class II	1991-09-06
K910649	Mdt/castle 10/90 Load Station	Mdt Biologic Co.	FLF	Class II	1991-09-06
K910159	Winged Adminin. Set W/non-Coring Needle	Dmd Products	FPA	Class II	1991-09-06
K905506	Accucore Telemetry, Modification	S & W Medico Teknik	DSI	Class II	1991-09-06
K904923	Infusa T Syringe Infusion Pump	Ferguson Medical	FRN	Class II	1991-09-06
K904164	Autovac (R) Autotransfusion System, 7900 Modified	Boehringer Laboratories, LLC	CAC	Class II	1991-09-06
K913679	Universal Swivel Patch	Bryman Medical	KNY	Class II	1991-09-05
K913553	Pin Dot Growth/dial Links	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913550	Pin Dot Trunion Mounts	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913549	Pin Dot Mounting Brackets	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913548	Pin Dot Aluminum Pan	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913546	Impala Casters	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913545	Pin Dot Flip-Down Abductor	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913511	Impala Axles	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913509	Impala Wheels	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913507	Armrest	Pin Dot Products, Inc.	KNN	Class I	1991-09-05
K913289	Masterpieces(tm)/micro/mini Systems	Storz Instrument Co.	HRS	Class II	1991-09-05
K912564	Mega Pericardiocentesis Kit	Mega Medical, Inc.	DQY	Class II	1991-09-05
K912530	Cardiocap Ii(tm)	Datex Medical Instrumentation, Inc.	DXN	Class II	1991-09-05
K912526	Gs-220 Hand Impairment Evaluation System	J-Tech, Inc.	LBB	Class II	1991-09-05
K912047	Wilson-Cook Russell Gastrostomy Kit	Wilson-Cook Medical Inc.	KNT	Class II	1991-09-05
K911625	Ames Dca 2000Tm Analyzer and Reagent System	Kulzer GmbH	LCP	Class II	1991-09-05