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 3412 of 3526

510(k) clearances, page 3412 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790652	Toguard	Togard, Inc.	IPG	Class I	1979-04-04
K790579	Medistor II	Cybermedic, Inc.	BTY	Class II	1979-04-04
K790538	Sponge Counter	Devon Industries, Inc.	LWH	Class I	1979-04-04
K790491	Itimized Instruments	E.M. Adams Co., Inc.	FZT	Class I	1979-04-04
K790469	Strep Blood Agar-5% Sheep Blood	Biomedia, Inc.	JSI	Class I	1979-04-04
K790457	Hemoglobin Controls	Data Medical Associates, Inc.	JPK	Class II	1979-04-04
K790442	Isotonic Diluent	Royco Instruments	GIF	Class I	1979-04-04
K790423	Factor V Deficient	Sigma Chemical Co.	GGP	Class II	1979-04-04
K790415	Hcp-7	Bioscientific	JPK	Class II	1979-04-04
K790387	Feeding Tube W/ Lubricant Coating	Biosearch Medical Products, Inc.	KNT	Class II	1979-04-04
K790376	Dupont Aca Ckmb Verifiers	E.I. Dupont de Nemours & Co., Inc.	JJX	Class I	1979-04-04
K790371	Macomb Lipid Control	Macomb Chemical Co.	JJY	Class I	1979-04-04
K790366	Urine Culture Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	JTW	Class I	1979-04-04
K790357	Cpk-Cs	Hoffmann-La Roche, Inc.	JHT	Class II	1979-04-04
K790341	Delta-Net	Johnson & Johnson Professionals, Inc.	KKX	Class II	1979-04-04
K790338	Colonoscope, Model Sc-4 Flexible Fiber	American Optical Corp.	FDF	Class II	1979-04-04
K790336	Union Carbide Corp. Computer Interface	Union Carbide Corp.	JQP	Class I	1979-04-04
K790329	A-Gent-Hdl Reagent	Abbott Medical	LBR	Class I	1979-04-04
K790309	Cpk Isoenzyme Substrate	Electrophoresis Corp.	JHY	Class II	1979-04-04
K790298	Radioassay, Control Serum I, II, III	Kallestad Laboratories, Inc.	DGR	Class I	1979-04-04
K790278	Analyzer, Centrifuchem System 400	Union Carbide Corp.	JJG	Class I	1979-04-04
K790268	Cortisol Ria Kit	E. R. Squibb & Sons, Inc.	CGR	Class II	1979-04-04
K790266	Spectacle Frames	Alva-Tech, Inc.	HQZ	Class I	1979-04-04
K790250	Liquisol Cortisol Ria Test Kit	Damon Corp.			1979-04-04
K790248	Nicotinamide-Adenine Ainucleotide (Nad)	Boehringer Laboratories, LLC	CFJ	Class II	1979-04-04
K790245	Standard Pectoralis Muscle Implant	Medical Engineering Corp.			1979-04-04
K790111	Atomizer, Furnace Model Hga-400	Revvity Health Sciences, Inc.	JXR	Class I	1979-04-04
K782166	Slide Test for Pregnancy, Gravindex 90	Ortho Diagnostics, Inc.	JHJ	Class II	1979-04-04
K782063	Pregnancy, Sensidex Tube Test	Ortho Diagnostics, Inc.	JHJ	Class II	1979-04-04
K781971	Knee System, Quadraxial Constrained	Hexcel Medical	KRO	Class II	1979-04-04
K790587	Canvas Wedge	Maddak, Inc.	IOD	Class I	1979-04-03
K790561	Offset Aluminum Cane	Maddak, Inc.	IPS	Class I	1979-04-03
K790558	Cersa-Cane	Maddak, Inc.	IPS	Class I	1979-04-03
K790557	Crutch	Maddak, Inc.	IPR	Class I	1979-04-03
K790547	Pro-Tab	Professional Tape Co., Inc.	KCT	Class II	1979-04-03
K790530	Push Ball Incline	Maddak, Inc.	ION	Class I	1979-04-03
K790529	Walking Aid	Maddak, Inc.	ITJ	Class I	1979-04-03
K790528	Therapy Gyroscope	Maddak, Inc.	KNL	Class I	1979-04-03
K790525	Hematrol S Hematology Controls	Fisher Scientific Company L.L.C.	JPK	Class II	1979-04-03
K790515	Behind-the-Ear Hearing Aid	Danavox, Inc.	ESD	Class I	1979-04-03
K790498	Liss Reagent	Fisher Scientific Company L.L.C.	KSG	Class II	1979-04-03
K790482	Model 4107-2S, Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1979-04-03
K790481	Model Fs1	Starkey Laboratories, Inc.	KHL	Class II	1979-04-03
K790480	Tulane Heat-Pack	Tulane	IMD	Class I	1979-04-03
K790479	A-Gent Immunoglobuline Test System	Abbott Medical	CZP	Class II	1979-04-03
K790454	Model 78801A Patient Monitors	Hewlett-Packard Co.	DRT	Class II	1979-04-03
K790437	Trach Care Kit	Abco Dealers, Inc.	BTO	Class II	1979-04-03
K790386	Lead Models Mum 1260, Mum 1290	Ela Medical, Inc.	DTB	Class III	1979-04-03
K790331	Zimmer Surgical Instrument Lubricant	Zimmer GmbH			1979-04-03
K790305	Electrodes, Ferris ECG, Types 905,906	Ferris Mfg. Corp.	DRX	Class II	1979-04-03