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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3482 of 3526

510(k) clearances, page 3482 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770900	Cast Brwm, Fracture	Chase Mfg. Co.	ITM	Class I	1977-07-21
K770899	Fracture Cast Brace, Poly	Chase Mfg. Co.	ITM	Class I	1977-07-21
K770898	Fracture Cast Brace Kit, Plastic	Chase Mfg. Co.	HSP	Class I	1977-07-21
K770877	Data Reduction System, Dp-3000	Beckman Instruments, Inc.	JQP	Class I	1977-07-21
K770827	Chromatography Analysis Sys, Model 8500	Varian Assoc., Inc.			1977-07-21
K770764	Tissue Culture Media W/hepes Buffer	Microbiological Assoc.	KIT	Class I	1977-07-21
K770690	Mask, Vapor, Monomer	Howmedica Corp.	JDY	Class I	1977-07-21
K771048	Catheters, Drainage	Axiom Medical, Inc.	FEG	Class II	1977-07-19
K771257	Acry Temp	Interstate Dental Co., Inc.	EBG	Class II	1977-07-15
K771254	Accu. Crown Cold Cure	Briar Cliff, Inc.	EBG	Class II	1977-07-15
K771252	Cb600, Turbine Control Bol	Litton Dental Products	EIA	Class I	1977-07-15
K771251	Hu:500, Hygienassist	Litton Dental Products	EIA	Class I	1977-07-15
K771249	Joy Light	M.D. Intl., Inc.	EAZ	Class I	1977-07-15
K771248	Silicone Impression Mateoial	Interstate Dental Co., Inc.	ELW	Class II	1977-07-15
K771247	Core Material	Star Dental Mfg. Co.	EBF	Class II	1977-07-15
K771246	Alarm Sys for Nitrous Oxide Sys.	Star Dental Mfg. Co.	ECX	Class I	1977-07-15
K771238	Rid Plates & Intensi. for Human Ige Etc	G.D. Searle and Co.	DGC	Class II	1977-07-15
K771233	Phenytoin Analytical Test Packs	E.I. Dupont de Nemours & Co., Inc.	DIP	Class II	1977-07-15
K771214	Superfine Diamonds	Den-Mat Corp.	EJL	Class I	1977-07-15
K771206	Av Fistula Needle Set	Terumo America, Inc.	FIE	Class II	1977-07-15
K771186	Micro Bi-Polar Forceps #39-200	Edward Weck, Inc.	HAM	Class II	1977-07-15
K771185	Periodontic Toothbrush, #0126-0190-00	Hoyt Laboratories	EFW	Class I	1977-07-15
K771184	Toothbrush, Orthodontic, #0126-0189-00	Hoyt Laboratories	EFW	Class I	1977-07-15
K771183	Toothbrush, Pedodontic, #0126-0188-00	Hoyt Laboratories	EFW	Class I	1977-07-15
K771179	Biobond Master Stain and Glaze Kit	Dentsply Intl.	ELL	Class II	1977-07-15
K771145	Will-Ceram W-2	Williams Gold Refining Co., Inc.	EJS	Class II	1977-07-15
K771130	Desensitron	Parker Laboratories, Inc.	EGJ	Class II	1977-07-15
K771128	Neko Ceramic Convenience Crowns	Sterndent Corp.	ELZ	Class I	1977-07-15
K771119	Pastes, Restorative & Tinted, Debtal	Espe Dental Products	EBF	Class II	1977-07-15
K771110	Heritage Special Alloy	Howmedica Corp.	EJT	Class II	1977-07-15
K771044	Tma Bicarbonate Diluent	Hyland Therapeutic Div., Travenol Laboratories	JJS	Class I	1977-07-15
K771024	Cholinesterase Reagent System	American Monitor Corp.	DLI	Class I	1977-07-15
K771000	Trendar	Hi Chem, Inc.	CGA	Class II	1977-07-15
K770982	United Skin Barrier	Howmedica Corp.	EXE	Class I	1977-07-15
K770972	Cardiozyme Ck-Total Reagents	Dade, Baxter Travenol Diagnostics, Inc.			1977-07-15
K770948	Lipoprotein Profiling System	Beckman Instruments, Inc.	JHL	Class I	1977-07-15
K770850	Tray, Blood Gas, Arterial, #4014	Concord Laboratories, Inc.	FMF	Class II	1977-07-15
K770824	Flame Photometer Molel 4600, Kda	American Monitor Corp.	JIH	Class II	1977-07-15
K770517	Nf Device	Rpr, Inc.	KPD	Class II	1977-07-15
K771223	Gray Tone Imaging Film	Eastman Kodak Company	IWZ	Class I	1977-07-14
K771211	Doppler (Utd-5 & Utd-6)	Terumo America, Inc.	HEK	Class II	1977-07-14
K771207	Terufusion Donor Set	Terumo America, Inc.	FMI	Class II	1977-07-14
K771205	Hypodermic Syringe	Terumo America, Inc.	FMF	Class II	1977-07-14
K771204	Surflo Winged Infusion Set	Terumo America, Inc.	FPA	Class II	1977-07-14
K771203	Disp. Hypodermic Needle	Terumo America, Inc.	FMI	Class II	1977-07-14
K771188	Reversing Click Generator Rcg6	Teca, Inc.	ETS	Class II	1977-07-14
K771181	Vaginal Illuminator, Model 78570	Welch Allyn Inc	HDG	Class I	1977-07-14
K771144	Rhodamine-Conjugated Antiserum	Kent Laboratories, Inc.	DBY	Class I	1977-07-14
K771142	T3 Clasp Ria Kit	E. R. Squibb & Sons, Inc.	CDP	Class II	1977-07-14
K771139	Crp-Wellcotest	Burroughs Wellcome Co.	DCN	Class II	1977-07-14