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 2026-10-15, 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 3235 of 3528

510(k) clearances, page 3235 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820741	Mr1 Lutropin Ria Kit	Microanalytic Research, Inc.	CEP	Class I	1982-04-14
K820726	Accuset (R) Cassette	Imed Ireland, Ltd.	FRN	Class II	1982-04-14
K820724	Fluorogen Pap Fia	Biogenex Laboratories, Inc.	JFH	Class II	1982-04-14
K820718	Argyle Thoracic Catheters	Sherwood Medical Co.	JOL	Class II	1982-04-14
K820716	Monoject 512 Syringes W/wo Needles	Sherwood Medical Co.	FMF	Class II	1982-04-14
K820683	Staphylococcus Latex Agglutination Kit	American Scientific Products	LHT	Class I	1982-04-14
K820682	Surgical Instruments	Intl. Needle, Inc.			1982-04-14
K820648	Arrow M.i.s. Multi-Lumen Catheteriza	Arrow Intl., Inc.	DQY	Class II	1982-04-14
K820642	Sickle-Check	Panmed, Inc.	GHM	Class II	1982-04-14
K820579	Flex-E1 ECG Electrode	Conmedcorp	DRS	Class II	1982-04-14
K820567	Trep Card Eiken	Syn-Kit, Inc.	GMQ	Class II	1982-04-14
K820531	Endo-Staph Teichoic Acid Antibody Kit	Meridian Diagnostics, Inc.	LHT	Class I	1982-04-14
K820447	Alpha Plasma Transfer Set	Alpha Therapeutic Corp.	KSB	Class II	1982-04-14
K820390	Histoset Immunoperoxidase Tissure Kit	Immulok, Inc.	LKH	Class I	1982-04-14
K820368	Lectin-a	American Dade	KSI	Class II	1982-04-14
K813157	Colorless Disposible Plastic Syringes	Sam Joo Industrial Co., Ltd.	FMF	Class II	1982-04-14
K820867	Percutaneous Nephrostomy Set	Van-Tec, Inc.	GBO	Class I	1982-04-13
K820812	Creatine Kinase-Mb Kit	Calbiochem-Behring Corp.	JHY	Class II	1982-04-12
K820853	Quantum Models 253-09, 254-09 254-10	Intermedics, Inc.	DXY	Class III	1982-04-09
K820833	Audicraft Vip Hearing Aid	Audina Hearing Instrument, Inc	ESD	Class I	1982-04-09
K820818	Concentrated Cleaner for Hard Contacts	Bausch & Lomb Incorporated	HPX	Unclassified	1982-04-09
K820781	Coat-a-Count Amikacin Ira	Siemens Healthcare Diagnostics Inc.	KLQ	Class II	1982-04-09
K820774	Implantable, Multiprogrammable	Biotronik Sales, Inc.	DXY	Class III	1982-04-09
K820767	Biopolar Tined Endocardial Lead 403B/60	Siemens Elema AB	DTB	Class III	1982-04-09
K820753	Amerlex Lh Ria Kit (Code Im2081)	Amersham Corp.	CEP	Class I	1982-04-09
K820751	Glaukon	Sonometrics Systems, Inc.	HKX	Class II	1982-04-09
K820738	Lustralloy	Hoyt Laboratories	EJJ	Class II	1982-04-09
K820737	Periscope Voice Prosthesis	Bivona Medical Technologies	EWL	Class II	1982-04-09
K820730	Micro Cise Diamond Scalpel	CooperVision, Inc.	GDX	Class I	1982-04-09
K820715	Middle Ear Analyzer (Impedance Audio	Grason-Stadler, Inc.	EWO	Class II	1982-04-09
K820706	Waterless Seal & Vacuum Regulator	Sorensen Research	KDP	Class II	1982-04-09
K820699	Catheter Guide Wire	Quest Medical, Inc	DQX	Class II	1982-04-09
K820693	Midwest Light Wand	American Midwest	EBZ	Class II	1982-04-09
K820689	C.s.r. Wrappers	General Medical Co.	FRG	Class II	1982-04-09
K820685	Denture Adjustment Kit	Camdent Laboratories	EBO	Class II	1982-04-09
K820680	Disposable Tubing Sets	Innovative Surgical Products, Inc.	KYG	Class I	1982-04-09
K820673	Self-Curing Hard Denture Liner	Coe Laboratories, Inc.	EBI	Class II	1982-04-09
K820670	Hs17/hs18 Series Monitors	Medtel Pty., Ltd.	FLL	Class II	1982-04-09
K820656	Rionet Hearing Aid Ha-57	Rion Acoustic Instruments, Inc.	ESD	Class I	1982-04-09
K820639	Obturation System Kit	U.S. Shizai Corp.	EKM	Class I	1982-04-09
K820638	Pediatric Sucker	3M Health Care, Sarns	KDC	Class I	1982-04-09
K820626	Opti-Disc	Video-Medical Devices, Ltd.	KQM	Class I	1982-04-09
K820625	Hemalet Automatic Lancet Device	Medprobe Laboratories	FMK	Class II	1982-04-09
K820622	Electrostimuli Aversion Machine	Michael R. Kiss	HCB	Class II	1982-04-09
K820618	Microsurgery Knife	Visitec Co.	HNN	Class I	1982-04-09
K820589	Economy Line of Trays	Abco Dealers, Inc.	FRG	Class II	1982-04-09
K820572	Argyle Delee Suction Catheter W/mucous	Sherwood Medical Co.	KTR	Class II	1982-04-09
K820568	Muscle Dysfunction Monitor	A Company, Inc.	DZM	Class I	1982-04-09
K820518	Gelman Glyco-Phore Buffer	Gelman Sciences, Inc.	JBD	Class II	1982-04-09
K820511	Bausch & Lomb Sterile All Purpose Solu	Bausch & Lomb Incorporated	HPX	Unclassified	1982-04-09