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 2026-10-21, 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 3010 of 3529

510(k) clearances, page 3010 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K842501	Tss/fik	Zarcon Corp.			1985-03-12
K850739	Amendment to Labeling Microtrak Hsv 1/Hsv 2 Direct	Syva Co.	GQL	Class II	1985-03-11
K850708	Spectronic 1001 - Clinical Spectrophotometer	Bausch & Lomb Incorporated	JJQ	Class I	1985-03-11
K850671	Impact 901 Series Port-a-Wall	ZOLL Medical Corporation	FOX	Class I	1985-03-11
K850667	Peridochrom Triglycerides Gpo	Boehringer Mannheim Corp.	CDT	Class I	1985-03-11
K850661	Matrix Dri-Idea Booties	Matrix Medica, Inc.			1985-03-11
K850595	3 X 4 Non-Adherent Pad	American White Cross, Inc.			1985-03-11
K850556	Cdc Anerobic Blood Agar W/pea, Anerobic Pea	Hardy Media	JSJ	Class I	1985-03-11
K850554	Lkv Agar, Lkv Anaerobic Agar	Hardy Media	JSJ	Class I	1985-03-11
K850553	Mueller Hinton Agar W/chocolate, Mh W/choc	Hardy Media	JTZ	Class II	1985-03-11
K850552	Bile Esculin Agar W/azide, Bea W/azide	Hardy Media	JSI	Class I	1985-03-11
K850551	Sim Medium	Hardy Media	JSE	Class I	1985-03-11
K850550	Simmons Citrate Agar	Hardy Media	JSF	Class I	1985-03-11
K850549	Todd Hewitt Broth	Hardy Media	JSG	Class I	1985-03-11
K850548	Lysine Iron Agar Lia	Hardy Media	JSE	Class I	1985-03-11
K850547	Motility Indole Ornithine Agar	Hardy Media	JSE	Class I	1985-03-11
K850546	Kligler Iron Agar Kia	Hardy Media	JSE	Class I	1985-03-11
K850545	Acetate Differential Agar	Hardy Media	JSF	Class I	1985-03-11
K850505	Deseret Epidural Catheter W/toughy-Borst Adapter	Parke-Davis Co.	BSO	Class II	1985-03-11
K850456	Tracheostomy Care Kit	Excel Health Care Products	BTO	Class II	1985-03-11
K850446	Tracheostomy Care Kit	Paco Research Corp.	BTO	Class II	1985-03-11
K850445	Tracheostomy Care Tray	Paco Research Corp.	BTO	Class II	1985-03-11
K850371	Intiwash Manual Microplate Washer	Inti Corp.	JTC	Class I	1985-03-11
K850227	Ham's Mixture F-12 Medium	Hazleton Research Products, Inc.	KIT	Class I	1985-03-11
K845038	Breast & Foreign Body Localization Instrument	Ranfac Corp.	GDF	Class I	1985-03-11
K844163	Ez 502	Aeg Power Tool Corp.	KIJ	Class I	1985-03-11
K844162	Ez 505	Aeg Power Tool Corp.	KIJ	Class I	1985-03-11
K843790	Tracheal Tube Fixation Device	Laerdal California, Inc.	CBH	Class I	1985-03-11
K842877	Absolute Vinyl Polysiloxane Impress	Coe Laboratories, Inc.	ELW	Class II	1985-03-11
K844890	Tell Me Tags - Nonpowered Communication Sys	Mina Manufacturers, Inc.	ILP	Class I	1985-03-08
K850655	Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2	Erika, Inc.	FJI	Class II	1985-03-07
K850654	Toray Indus. Filtryzer Hollow Fiber Artificial Kid	Erika, Inc.	FJI	Class II	1985-03-07
K850558	Corn Meal Agar W/polysorbate 80, Corn Meal W/polys	Hardy Media	JSG	Class I	1985-03-07
K850557	Selective Strep Agar	Hardy Media	JSJ	Class I	1985-03-07
K850507	Critikon i.v. Administraion Set	Critikon Company, LLC	FPA	Class II	1985-03-07
K850492	Nasal Septal Button	Santa Barbara Medco, Inc.	LFB	Unclassified	1985-03-07
K850287	Mentor Percutaneous Malecot Nephrostomy Set	Mentor	LJE	Unclassified	1985-03-07
K850237	Ebss W/o Ca & Mg	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850236	Bme Amino Acids 100X	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850235	Bme Vitamins 100X	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850234	H-Mem Powdered Medium	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850233	Mem Essential Amino Acids 50X	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850232	E.mem Powdered Medium	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850228	Ham's Mixture F-10 Medium	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850226	Mccoy's Medium 5A, Iwakata & Grace Modifica-	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850225	Fischer's Medium	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850223	Earle's Mem W/non-Essential Amino Acids Powder Med	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850220	Alpha Mem W/o Nucleosides Powder Medium	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850219	Mem W/spinner Salts Powder Medium	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07
K850218	Swim's S-77 Powder Medium	Hazleton Research Products, Inc.	KIT	Class I	1985-03-07