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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2283 of 3531

510(k) clearances, page 2283 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K926112	Accutex Beta-Hcg Test	J.S. Medical Assoc.	JHJ	Class II	1993-07-28
K926107	Arcom Polyethylene Acetabular Liners & Components	Zimmer GmbH	LPH	Class II	1993-07-28
K925599	Fujinon Video Laparoscope-Additional Intended Use	FUJIFILM Healthcare Americas Corporation	GCJ	Class II	1993-07-28
K925226	Sight-Plus Arthroscope	American Medical Concepts, Inc.	HRX	Class II	1993-07-28
K925066	Pneumatic Irrigation Standard	Arthrodyn, Inc.	FOX	Class I	1993-07-28
K924748	Vital-Port Vasc Access 901Op/911op/9012p/9112p	Med Institute, Inc.	LJT	Class II	1993-07-28
K924337	Pleur-Evac(r) Adult/pedi Dual Coll Chest Drain Sys	Deknatel, Inc.	GCX	Class II	1993-07-28
K923508	Triglycerides Gpo-Pap	Randox Laboratories, Limited	CDT	Class I	1993-07-28
K923448	Empty Solution Transfer Container W/ Detach Leg	Healthtek, Inc.	KPE	Class II	1993-07-28
K921902	Port Access Needle	Kawasumi Laboratories Co., Ltd.	LJT	Class II	1993-07-28
K915363	Sarns 7850 Centrifugal Pump (Modified)	3M Company	KFM	Class II	1993-07-28
K933113	Starkey Trilogy II Programmable Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1993-07-27
K932735	Phonak Pico-Forte Sc-D-2	Phonak, Inc.	ESD	Class I	1993-07-27
K932734	Phonak Pico-Forte Sc-2	Phonak, Inc.	ESD	Class I	1993-07-27
K932242	Radioactive Samarium 145 Seeds/sources #2341-2345	Best Industries	KXK	Class II	1993-07-27
K932081	Lighted Intubation Sylet	Aaron Medical, Inc.	BSR	Class I	1993-07-27
K932044	Du Pont Ise Sensor Cartridge/revised Tco2 Electrod	Dupont Medical Products	CEM	Class II	1993-07-27
K931998	Lcr Generator	Philips North America LLC	IZO	Class I	1993-07-27
K931889	Creatine Kinase Test	Em Diagnostic Systems, Inc.	CGS	Class II	1993-07-27
K931888	Total Bilirubin	Em Diagnostic Systems, Inc.	CIG	Class II	1993-07-27
K931657	Nuclear Associates Model 34-070 Brachytherapy Cal.	Victoreen, Inc.	KPT	Class II	1993-07-27
K931601	Chemiluminescence Dhea-S Immunoassay	Nichols Institute	JKC	Class I	1993-07-27
K931403	Siterite Needle Guide (Modified)	Dymax Corp	DQY	Class II	1993-07-27
K931353	Floss Plus	Floss Plus, Inc.	JES	Class I	1993-07-27
K931297	Gca-7200A	Toshiba America Medical Systems, In.C	KPS	Class II	1993-07-27
K931031	Vidas Cortisol (Cort) Assay & Serum Free Dilutent	Biomerieux Vitek, Inc.	JFT	Class II	1993-07-27
K931028	Valleylab Retractable Electrodes	Medtronic, Inc.	GEI	Class II	1993-07-27
K930732	Delfia Cortisol Kit	Wallac Oy	JFT	Class II	1993-07-27
K930279	Refix(tm) System	Nomos Corp.	IYE	Class II	1993-07-27
K930234	Flh1768m Series Hospital Bed	Bertec Medical, Inc.	FNL	Class II	1993-07-27
K930218	Subcutaneous Tunneling Needle and Handles	Concord/Portex	MAJ	Class II	1993-07-27
K926396	Adrenocorticotropic/acth Analysis Product	Nichols Institute	CKG	Class II	1993-07-27
K926184	Douglas Medical Products, Inc. Vented Spike Adapt	Douglas Medical Products, Inc	FPA	Class II	1993-07-27
K926140	Vacuum Power Body Fluid Suction Apparatus	Hill-Rom Inc.	KDP	Class II	1993-07-27
K926045	Skytron Life Island 21	Skytron, LLC	FNM	Class II	1993-07-27
K925651	Life Island 21	Keisei (USA) Co., Ltd.	FNM	Class II	1993-07-27
K925349	One System Tapered Titanium Abutments	Implant Support Systems, Inc.	NHA	Class II	1993-07-27
K925219	Ivion Admin Sets W/flow Clips	Ivion Corp.	FPA	Class II	1993-07-27
K924275	Restraining Stretcher	Dms	FPP	Class I	1993-07-27
K923883	Dental or Surgical Bur	Stratum Dental Technologies, Inc.	EJL	Class I	1993-07-27
K923808	Muller Straight Stem Femoral Prosthesis	Techmedica, Inc.	LZO	Class II	1993-07-27
K914724	Ada Shank Extension	Implant Corp. of America	DZA	Class I	1993-07-27
K933095	351-Agco Behind-the-Ear Hearing Aid	Telex Communications, Inc.	ESD	Class I	1993-07-26
K933017	Model 5030 Suction Handpiece System	Sunrise Technologies, Inc.	GEX	Class II	1993-07-26
K932988	Accessories for Endoscopes for Sinus Surgery	Smith & Nephew Richards, Inc.	EOB	Class II	1993-07-26
K932675	Gxp Dental X-Ray Processor	Gendex Corp.	EGN	Class I	1993-07-26
K932662	Cyclosporine (Whole Blood) Control-Pediatric Level	More Diagnostics Inc.	LAS	Class I	1993-07-26
K932565	Fujifilm Ec-B Series Casette	FUJIFILM Healthcare Americas Corporation	IXA	Class II	1993-07-26
K932357	Fuji Ec Id Camera	FUJIFILM Healthcare Americas Corporation	JAC	Class I	1993-07-26
K932166	Silicone Tympanostomy Tubes	Smith & Nephew Richards, Inc.	ETD	Class II	1993-07-26