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 2954 of 3529

510(k) clearances, page 2954 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852181	Electrocardiograph	Armstrong Ind., Inc.	DPS	Class II	1985-10-09
K853910	Suture Removal Kit	Scientific & Medical Care Co.	KDD	Class I	1985-10-08
K853883	Tubing a Vit, Vit, Frag Packs & Needle & Clean Wir	Medical Corp. of America	HQC	Class II	1985-10-08
K853829	Meniscal Repair System	Concept, Inc.			1985-10-08
K853801	Meniscal Stitching Kit	Aspen Laboratories, Inc.			1985-10-08
K853742	Gauze Sponge	South Mountain Medical	GDY	Class I	1985-10-08
K853623	Chiba, Madayag, Potts-Cournand, Seldinger Biopsy N	Co-Medical, Inc.			1985-10-08
K853603	Cantrol Urine Dipstick Control Two Levels	Canyon Diagnostics, Inc.	JJW	Class I	1985-10-08
K853520	Lifeline Endocardial Unipolar 487-06 Tle Lead	Intermedics, Inc.	DTB	Class III	1985-10-08
K853839	Pennine Link Tubing	Samco Industries, Inc.			1985-10-07
K853802	Ats 500 Tourniquet	Aspen Laboratories, Inc.	KCY	Class I	1985-10-07
K853800	Upper-Chest-Support Cushion for Operations in Sitt	Cedar Surgical, Inc.			1985-10-07
K853799	Neurosurgical Headrest	Cedar Surgical, Inc.			1985-10-07
K853798	Bone Impactors	Cedar Surgical, Inc.			1985-10-07
K853797	Kneeling Attachment & Cushioned Face Rest Sys for	Cedar Surgical, Inc.			1985-10-07
K853796	Raylor Retractors	Cedar Surgical, Inc.	GAD	Class I	1985-10-07
K853764	Tendon Leader	Mizuho Orthopedic Systems Inc			1985-10-07
K853763	Tendon Stripper	Mizuho Orthopedic Systems Inc			1985-10-07
K853762	Isometric Acl Drill Guide	Mizuho Orthopedic Systems Inc	GEY	Class I	1985-10-07
K853761	Drilling Template	Mizuho Orthopedic Systems Inc	GEY	Class I	1985-10-07
K852860	Model 920 Argon/dye Laser-for Dermatological/use	Coherent Medical Group	GEX	Class II	1985-10-07
K852381	Falcon (Powered Wheelchair)	Venturego, Inc.	ITI	Class II	1985-10-07
K852199	Osteograf 2040 Osteograf 4060	Osteotech Inc	LYC	Class II	1985-10-07
K851405	Trimedyne Medical Argon Laser System Model 700	Trimedyne, Inc.	GEX	Class II	1985-10-07
K853933	Quantimetrix Human Serum Therapeutic Drug Control	Quantimetrix Corp.	DIF	Class I	1985-10-04
K853931	Quantimetrix Human Serum Chemistry Control	Quantimetrix Corp.	JJY	Class I	1985-10-04
K853906	Liqui-Sera Chemistry Controls (Comprehensive)	Biodiagnostic Intl	JJY	Class I	1985-10-04
K853891	Indirect Ophthalmoscope	Carl Zeiss, Inc.	HLJ	Class II	1985-10-04
K853871	Qca Enzymatic Cholesterol	BD Becton Dickinson Vacutainer Systems Preanalytic	CHH	Class I	1985-10-04
K853867	Pantex Direct Dhea-S Coated Tube Radioimmunoassay	Pantex, Div. Bio-Analysis, Inc.	JKC	Class I	1985-10-04
K853832	Lytening 1	Amdev, Inc.	JGS	Class II	1985-10-04
K853790	Babe Shade-Infant Ambient Light Intensity Reducer	Rocky Mountain Medical Corp.	HQY	Class I	1985-10-04
K853789	Additional Hemotec Hepcon/sys B-10 Coagulation Car	Hemotec, Inc.	JPA	Class II	1985-10-04
K853784	C-Terminal Pth Ria Kit	Diagnostic Systems Laboratories, Inc.	CEW	Class II	1985-10-04
K853735	Colorado Medical Model Ctm-3000	Colorado Medical, Inc.	FIZ	Class II	1985-10-04
K853703	Ventrezyme T3 Immunoassay T3	Vxr, Inc.	CDP	Class II	1985-10-04
K853550	Travenol Capd Y Set 5C4354	Travenol Laboratories, S.A.	KDJ	Class II	1985-10-04
K853530	Endo Dynamics Gastrointestinal Cytology Brush	E-Z-EM, Inc	FDX	Class II	1985-10-04
K853514	Rigid Endoscope	American Edwards Laboratories	GCM	Class II	1985-10-04
K853382	Maid Mentor Aspiration/irrigation Devro	Mentor O & O, Inc.	HQE	Class II	1985-10-04
K853358	Reliance Pendulum Ophthalmic Delivery System	Dentsply Intl.	HMF	Class I	1985-10-04
K853308	Keates Irrigation/aspiration/vitreous Cutter 5000	Frigitronics of Connecticut, Inc.	HQE	Class II	1985-10-04
K853288	Feeding Units & Tubes	I M, Inc.	KNT	Class II	1985-10-04
K853285	Mywasher 5	Scientific Sales Intl., Inc.	LIB	Class I	1985-10-04
K853284	Myreader 7	Scientific Sales Intl., Inc.	JJQ	Class I	1985-10-04
K853198	Additional Hemotec Act Coagulation Cartridges	Medical Device Consultants, Inc.	JPA	Class II	1985-10-04
K853170	International Model Sc Custom in the Ear Hearg Aid	Int'L Hearing Aids, Inc.	ESD	Class I	1985-10-04
K853119	Urodyn 1000	Dantec Electronics, Inc.	FFO	Class I	1985-10-04
K853104	Disposable, Sterile Biopsy Punch	August C. Stiefel Research Institute, Inc.	FCI	Class II	1985-10-04
K852520	Aca Fibrin Degradation Prod Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	GHH	Class II	1985-10-04