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 2026-10-22, 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 2891 of 3529

510(k) clearances, page 2891 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860999	Gilford Uniqual Abnormal Control Serum/assayed	Ciba Corning Diagnostics Corp.	JJY	Class I	1986-07-02
K860924	Ramp Progesturine Pdg Assay--48 Test Kit	Monoclonal Antibodies, Inc.	JLS	Class I	1986-07-02
K860867	Digital Subtraction Angiography Catheters and Sets	Medical Components, Inc.	DQO	Class II	1986-07-02
K860782	Gen-Probe Mycobacterium Rapid Confirmation System	Hologic, Inc.	LQF	Class I	1986-07-02
K855202	Glucometer M Blood Gulcose Meter	Miles Laboratories, Inc.	CGA	Class II	1986-07-02
K851639	Anti-Leu-12 B Cell Reagent	BD Becton Dickinson Vacutainer Systems Preanalytic	LJD	Class II	1986-07-02
K862416	Fti 100 Medical Thermal Imager	Parexel Intl. Corp.	LMC	Class II	1986-07-01
K862415	Type 633 Computed Radiography (Cr) Film	Parexel Intl. Corp.	IWZ	Class I	1986-07-01
K862375	Cardio Port 500 24-H ECG Ambulatory Monitor System	Grandcor Medical Systems	DSI	Class II	1986-07-01
K862331	Fujitsu Malleable - Tip Brain Spatula	Downs Surgical, Ltd.	HAO	Class I	1986-07-01
K862299	Amresco Flow Pac Total Bilirubin Reagents	Amresco, Inc.	CIG	Class II	1986-07-01
K862256	Alkaline Phosphatase (Pnpp Rate) Reagent Set	Sterling Diagnostics, Inc.	CJE	Class II	1986-07-01
K862210	Urea Nitrogen (Gldh) Reagent Set (UV)	Sterling Diagnostics, Inc.	CDQ	Class II	1986-07-01
K862186	Lyphochek Glycated Hemoglobin/whole Blood/lev.i&ii	Bio-Rad	JPK	Class II	1986-07-01
K862179	Somas Liquid Urine Control	Somas Medical Industries, Inc.	JJY	Class I	1986-07-01
K862007	Hcg Irma, Cat. No. Cr-1501	Pacific Biotech, Inc.	JHI	Class II	1986-07-01
K861897	Uniskan II	Flow Laboratories, Inc.	JJQ	Class I	1986-07-01
K861878	Byron Suction Tips	Byron Medical			1986-07-01
K861865	Erie-Neb	Erie Medical	BTI	Class II	1986-07-01
K861719	Modified Models 8320/8322/8329/8316/8317/8318	Medtronic, Inc.	DXY	Class III	1986-07-01
K861696	Electrolyte Analyzer Accessory for Hitachi 704	Boehringer Mannheim Corp.	JGS	Class II	1986-07-01
K861674	Chloride Procedure	Data Medical Associates, Inc.	CHJ	Class II	1986-07-01
K861673	Bicarbonate Procedure	Data Medical Associates, Inc.	KHS	Class II	1986-07-01
K861670	Triglyceride (Trinder) Procedure	Data Medical Associates, Inc.	CDT	Class I	1986-07-01
K861666	Blood Urea Nitrogen (Bun) Procedure	Data Medical Associates, Inc.	CDQ	Class II	1986-07-01
K861664	Amylase Procedure	Data Medical Associates, Inc.	CIJ	Class II	1986-07-01
K861661	Inorganic Phosphorus Procedure	Data Medical Associates, Inc.	CEO	Class I	1986-07-01
K861655	Creatinine Procedure	Data Medical Associates, Inc.	CGX	Class II	1986-07-01
K861479	Cavafix, Central Venous Catheter Kit	Burron Medical Products, Inc.	FOZ	Class II	1986-07-01
K861384	Non-Adhering Dressing with Povidone-Iodine	Johnson & Johnson Professionals, Inc.	FRO	Unclassified	1986-07-01
K861314	Cholesterol Calibrators	Sigma Diagnostics, Inc.	JIT	Class II	1986-07-01
K861172	Rotavirus Latex Agglutination Assay	Bartels Immunodiagnostic Supplies, Inc.	LIQ	Class I	1986-07-01
K861158	S&w Type 888 Electrode	National Medical Technology	DRX	Class II	1986-07-01
K860835	Cephalostat	Dallas Dental Co.	EHD	Class II	1986-07-01
K860634	Panasonic Blood Pressure Meter, Zh-852Ap, Zh-858Pp	Panasonic Co. Div. Matsu Elec. Corp. America	DXN	Class II	1986-07-01
K860210	Elefix Electrode Cream	Nihon Kohden America Inc	GYB	Class II	1986-07-01
K862216	Toxoplasma Gondii Igg Eia Test Kit (Amendment)	Labsystems, Inc.	LGD	Class II	1986-06-30
K862195	Rapid Bacteriuria Screen (Rbs)	New Horizons Diagnostics Co.	JXA	Class I	1986-06-30
K862109	Enzymun Test Tbg	Boehringer Mannheim Corp.	CEE	Class II	1986-06-30
K862020	Heat/moisture Exchanger, Hme, W/integral Filter	Intertech/Ohio	BYD	Class I	1986-06-30
K861771	Meta - Health Model Mtg III	Meta Health, Inc.	FLL	Class II	1986-06-30
K861335	Storz Compuscan 68K	Storz Instrument Co.	IYO	Class II	1986-06-30
K861208	Intelliject Medication Syringe	Intelligent Medicine, Inc.	FRN	Class II	1986-06-30
K861207	Intelliject Infusion Pump	Intelligent Medicine, Inc.	FRN	Class II	1986-06-30
K860579	Cardioscan Doppler Option	Interspec, Inc.	JOP	Class II	1986-06-30
K853565	Artis Ultrasound Imaging System	Philips North America LLC	IYO	Class II	1986-06-30
K862249	Tsh Irma Kit	Pacific Biotech, Inc.	JLW	Class II	1986-06-27
K862218	Double Antibody Cocaine Metabolite Ria Kit	Siemens Healthcare Diagnostics Inc.	KLN	Class II	1986-06-27
K862214	Emit Quinidine Assay	Syva Co.	LBZ	Class II	1986-06-27
K862168	Raichem Cholinesterase Reagent	Reagents Applications, Inc.	DIH	Class I	1986-06-27