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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2625 of 3530

510(k) clearances, page 2625 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K893684	Ciba Corning Magic Lite Folate Immunoassay	Ciba Corning Diagnostics Corp.	CGN	Class II	1989-07-27
K893589	Multi-Gas Analyzer (Mga)	Marquette Gas Analysis Corp.	CCK	Class II	1989-07-27
K893120	Kit, Intravenous Extension Tubing	Island Medical	FPA	Class II	1989-07-27
K893032	Pacer R 9 Treadmill	Pacer Industries, Inc.	IOL	Class I	1989-07-27
K892930	Technicon Dax Tm System Additional Analytes	Technicon Instruments Corp.	CKA	Class I	1989-07-27
K891920	Ad-Tech's Depth Electrode	AD-Tech Medical Instrument Corp.	GZL	Class II	1989-07-27
K890449	Permagum Putty Soft & Permagum Garrant	Wacker-Chemie GmbH	ELW	Class II	1989-07-27
K890120	Syringe Infusion Pump	Medfusion, Inc.	FRN	Class II	1989-07-27
K890114	Imex Rhythm Tek	Racom, Inc.	DSH	Class II	1989-07-27
K884972	Transcoutaneous Electro-Neuro Stimulator	Futuremed Div. of Future Impex Corp.	GZJ	Class II	1989-07-27
K884271	Acuson S328 Transducer for Fetal Pulsed Doppler	Acuson Corp.	IYO	Class II	1989-07-27
K894364	Modified Kronus Test Kit for Antibodies to (Tpo)	Kronus, Inc.	JZO	Class II	1989-07-25
K894338	Acs Animal Plasma Coagulation Control Level III	Analytical Control Systems	GGC	Class II	1989-07-25
K894303	Medscope 4Mm Arthroscope	Medscope Corp.	HRX	Class II	1989-07-25
K894205	Tecnol Silk Strip	Tecnol New Jersey Wound Care, Inc.	FPX	Class I	1989-07-25
K894203	Anti-Thyroglobulin Test Kit	Kronus, Inc.	JZO	Class II	1989-07-25
K894136	World Chair	Invacare GmbH	IOR	Class I	1989-07-25
K894112	Raomer	Niagara Corp.	INI	Class II	1989-07-25
K894045	Modified Polychrome IV Stain	Devetec, Inc.	KFD	Class I	1989-07-25
K894012	Miniclinic Pregnancy Test	Vanguard Biomedical Corp.	JHI	Class II	1989-07-25
K893986	New West Sunglasses	New West Promotions	HQY	Class I	1989-07-25
K893971	Acs Animal Plasma Coagulation Control Level II	Analytical Control Systems	GGC	Class II	1989-07-25
K893970	Acs Human Plasma Coagulation Control Level II	Analytical Control Systems	GGC	Class II	1989-07-25
K893966	Hdl Precipitating Reagent	Diagnostic Systems	LBR	Class I	1989-07-25
K893959	P.s.a. Femoral Hip Prosthesis	Protek, Inc.	KWY	Class II	1989-07-25
K893895	Hematology Control Mixtures for Quality Control	Intercare Diagnostics, Inc.	JPK	Class II	1989-07-25
K893835	Dau I, Dau II, Dau III and Dau IV Control Urine	Ciba Corning Diagnostics Corp.	DIF	Class I	1989-07-25
K893815	Hycor Sentry(tm) Drugs of Abuse Urine Calibrators	Hycor Biomedical	DKB	Class II	1989-07-25
K893801	M.f.s. Low Air Loss Pulsating Bed	Medical Flotation Systems, Inc.	IOQ	Class II	1989-07-25
K893775	Du Pont Dimension Psid Clinical Chemistry System	E.I. Dupont de Nemours & Co., Inc.	JQW	Class I	1989-07-25
K893676	Abbott Testpack Chlamydia	Abbott Medical	LJC	Class I	1989-07-25
K893465	Cmv Igm Antibody Test (Indirect Fluorescent Test)	IMMUNO CONCEPTS, NA, Ltd.	LKQ	Class II	1989-07-25
K893454	Chair/stool Unit Dental Oper., Portable, Field	Atlantic Industries, Inc.	KLC	Class I	1989-07-25
K893128	Stanbio Enzymatic Urea Nitrogen Determinat #2010	Stanbio Laboratory	CDL	Class II	1989-07-25
K892906	60 Microbore Extension Set W/anti-Siphon Valve	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1989-07-25
K892651	Songer Wiring System	Danek Medical, Inc.	LRN	Class II	1989-07-25
K892429	Injection Port for---Intermittent Injection	The Medi-Dose Group	FPA	Class II	1989-07-25
K892237	The Fern Cryoprobe	Cryogenic Instruments & Equipment, Ltd.	GEH	Class II	1989-07-25
K891767	Genetic Systems Microplate Reader	Genetic Systems Corp.	JJQ	Class I	1989-07-25
K891603	Body Cooler or Coolvest or Alpha Body Cooler	Alpha Rehabilitation Products	ILO	Class II	1989-07-25
K891023	Siemens Ceiling Stand 800F, 800 and 810	Siemens Medical Electronics	LDQ		1989-07-25
K890843	Lyme Disease Microassay	Diamedix Corp.	LSR	Class II	1989-07-25
K885096	Phyne-Vu	Medical Resources, Ltd.	FRO	Unclassified	1989-07-25
K894326	Thoracentisis Kit	Mill-Rose Laboratory	GAA	Class I	1989-07-24
K893864	Latex Examination Gloves	In Medicine, Inc.	LYY	Class I	1989-07-24
K893828	Ml-800 Autoelectronic Light Source	M.P. Video, Inc.	FST	Class II	1989-07-24
K893742	Filtral Tm 20 Hemodialyzer/filter	Hospal Medical Corp.	KDI	Class II	1989-07-24
K893712	Peritoneal Dialysis System and Access.	Delmed, Inc.	KDJ	Class II	1989-07-24
K893679	Shunt Connectors	Akcess Medical Products, Inc.	FJQ	Class I	1989-07-24
K893677	Hollow Fiber Dialyzer Focus 70H	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1989-07-24