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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3279 of 3528

510(k) clearances, page 3279 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K812050	Kallestad Antisera to Gentamicin	Kallestad Laboratories, Inc.	DJI	Class II	1981-08-03
K812030	Kodak Ektachem Clin. Chem. Slides (Alb)	Eastman Kodak Company	CIX	Class II	1981-08-03
K812029	Kodak Ektachem Clin. Chem. Slides (Trig)	Eastman Kodak Company	CDT	Class I	1981-08-03
K812028	Kodak Ektachem Clin. Chem. Slides (Tp)	Eastman Kodak Company	CEK	Class II	1981-08-03
K812027	Kodak Ektachem Clin. Chem. Slides (Amyl)	Eastman Kodak Company	CIW	Class II	1981-08-03
K812000	Pediatric Double Swivel Connector	Mallinckrodt Critical Care	BZA	Class I	1981-08-03
K811993	Radioimmunoassay, Follicle Stimulating	Endocrine-Metabolic Center	CGJ	Class I	1981-08-03
K811940	Oreia II, B-Hcg	Organon LLC	JHJ	Class II	1981-08-03
K811914	Flu Ven i.v. Sets	Venusa Ltd.	FPA	Class II	1981-08-03
K811879	Model a Unipolar Endocardial Lead	Cook Pacemaker Corp.	DTB	Class III	1981-08-03
K811878	Model B Bipolar Endocardial Lead	Cook Pacemaker Corp.	DTB	Class III	1981-08-03
K811877	Model C Unipolar Endocardial Lead	Cook Pacemaker Corp.	DTB	Class III	1981-08-03
K811876	Model D Bipolar Endocardial Lead	Cook Pacemaker Corp.	DTB	Class III	1981-08-03
K811758	Accu-Chek Trans-Telephonic Pacemaker Tr	Powers Medical Systmes	DXH	Class II	1981-08-03
K811546	Nicholas II, Viral-Bacterial Filter	K & G Healthcare Ind., Inc.	CAH	Class II	1981-08-03
K811372	Model 84 Transport System	Datascope Corp.	DSP	Class II	1981-08-03
K811364	Axicare Breast Shell	Neonatal Corp.	HFS	Class I	1981-08-03
K810796	Suntan Booth	Gibson'S Mfg. Corp.	FTC	Class II	1981-08-03
K810459	Three Level Control Sera	BD Becton Dickinson Vacutainer Systems Preanalytic	DHX	Class II	1981-08-03
K812058	Akron Urinary Drainage Bat	Latex Ind., Inc.	KNX	Class II	1981-07-31
K812057	Vance Cystoscopic	Vance Products, Inc.	FBK	Class II	1981-07-31
K812042	Infusion Pump Model 200/201	Medix Medical Electronics (U.S.A.), Inc.	FRN	Class II	1981-07-31
K812022	Zee Manual Resuscitator	Zee Medical Products Co., Inc.	BTM	Class II	1981-07-31
K812021	Volumetric Infusion Pump	American Edwards Laboratories	FRN	Class II	1981-07-31
K811977	Hemasite Access Monitor (Tent.) #Rs-8200	Renal Systems, Inc.	KOC	Class II	1981-07-31
K811973	Forder Retractor	Surgemed Marketing, Inc.	KOA	Class I	1981-07-31
K811956	Autonorm & Nerv-a-Norm	Autonomic Equipment Supply Co	KNM	Class I	1981-07-31
K811937	Argyle Tartan Tracheal Tube	Sherwood Medical Co.	BTR	Class II	1981-07-31
K811892	Cordis Dow Sera Flo Tm Transducer Prot	Cordis US Corp.	FIB	Class II	1981-07-31
K811865	Vma Pediatric Apnea Mattress	Vickers America Medical Corp.	BZQ	Class II	1981-07-31
K811864	Sigma Procedure 265-UV	Sigma Chemical Co.	CED	Class I	1981-07-31
K811855	Skin Scrub Kits	Oem Medical Div.	KDD	Class I	1981-07-31
K811814	Triangular Bandage	Abco Dealers, Inc.	NAB	Class I	1981-07-31
K811803	Japanese Hotzie	Consolidated Health & Sports Prod.	IMD	Class I	1981-07-31
K811799	Clear-Mount	Richard-Allan Medical Ind., Inc.	LEB	Class I	1981-07-31
K811793	Fix-Right 90Ml & 180 Ml Prefilled Cont	Richard-Allan Medical Ind., Inc.	KDT	Class I	1981-07-31
K811782	Soft & Stroke	Phoenix Intl. Marketing, Inc.	ISA	Class I	1981-07-31
K811628	Oeco Apnea Monitor	Oeco	BZQ	Class II	1981-07-31
K811384	Hemasite Vascular Access Shunt	Renal Systems, Inc.	FIQ	Class II	1981-07-31
K811245	Ophthalmic Scissors	Keeler Instruments, Inc.	HNF	Class I	1981-07-31
K811170	D-3160 Sorbent Cartridge	bioMerieux, Inc.	FKT	Class II	1981-07-31
K810746	Lumac's Bacteriuria Screening Kit	Lumac	JXA	Class I	1981-07-31
K811351	Veri-Fier	Verite	GZJ	Class II	1981-07-30
K812037	Temperature Monitor 130/131/133	Medix Medical Electronics (U.S.A.), Inc.	FLL	Class II	1981-07-28
K812035	Imed Accuset Cassette	Imed Corp.	FRN	Class II	1981-07-28
K812023	Monoject Sterile M506 6Cc Syringes	Sherwood Medical Co.	FMF	Class II	1981-07-28
K812013	Fluorescent Antibody Conjugate for Gp.a	Springwood Microbiologicals	GTX	Class I	1981-07-28
K812011	Blade Gauge	Koi, Inc.	HOE	Class I	1981-07-28
K812010	Koi Lacrimal Intubation System	Koi, Inc.	HMX	Class I	1981-07-28
K812009	Cardiotomy Reservoir W/filter#bcr-3500	Bentley Laboratories, Inc.	DTN	Class II	1981-07-28