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 3126 of 3528

510(k) clearances, page 3126 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832256	Goat Anti-Human Immunoglobulins-	Gelco Diagnostics, Inc.	DFH	Class II	1983-10-31
K832184	Simpliscriptor Ek 31/101 037 16	Litton Medical Electronics	DPS	Class II	1983-10-31
K832130	Multiscriptor Ek 36/101 047 02,05	Litton Medical Electronics	DPS	Class II	1983-10-31
K832090	Scd Skin Temp. Sensors #3400 Etc	Science Development Corp.	FLL	Class II	1983-10-31
K832018	Servomed Compact Monitor 181/10105002	Litton Medical Electronics	DRT	Class II	1983-10-31
K832017	Lme Blood Pressure Monitor	Litton Medical Electronics	DSK	Class II	1983-10-31
K832015	Multiscriptor Ek Various #43	Litton Medical Electronics	DPS	Class II	1983-10-31
K832014	Multiscriptor Ek #403 Various Model	Litton Medical Electronics	DPS	Class II	1983-10-31
K832013	Lme Patient Monitor Sms 151	Litton Medical Electronics	DPS	Class II	1983-10-31
K832012	Medical Electronics-Printer Clock	Litton Medical Electronics	DSF	Class I	1983-10-31
K831914	Strung Neuro Sponge Patties-X-Ray-	Ormed Mfg., Inc.	GDY	Class I	1983-10-31
K831912	Round-Beehive- Dissectors 3/8	Ormed Mfg., Inc.	GDI	Class I	1983-10-31
K831818	Central Station Monitor Csm-100	Honeywell, Inc.	DRT	Class II	1983-10-31
K831817	Patient Monitor #Rm-100	Honeywell, Inc.	DRT	Class II	1983-10-31
K831776	Capnograph	Datascope Corp.	CCK	Class II	1983-10-31
K831454	Lastoband Adhesive Bandages	Smith & Nephew, Inc.	NAD	Class I	1983-10-31
K831194	Glucokey	Ulster Scientific, Inc.	CGA	Class II	1983-10-31
K830429	Weil Perfusometer #100	ELITechGroup Inc	FLL	Class II	1983-10-31
K833301	Feeley-Gorman Agar	Neogen Culture Media	JSI	Class I	1983-10-28
K833296	Sabouraud Dextrose Agar, Emmons	Neogen Culture Media	JSG	Class I	1983-10-28
K833267	Respir Gard-II Oxygard Hydrogard-Spiro	Marquest Medical Products, Inc.	CAH	Class II	1983-10-28
K833260	Stain Pack for Aerospray Slide Stainer	ELITechGroup Inc	IAF	Class I	1983-10-28
K833254	Streptococcus Id Triplate System	Granite Diagnostics, Inc.	JSI	Class I	1983-10-28
K833243	Mammographic S-Ray System	Xerox Medical Systems	IZH	Class II	1983-10-28
K833241	Intrex	Pennwalt Corp.	EAP	Class II	1983-10-28
K833238	Crisa	X-Ray Tube Corp.	ITY	Class I	1983-10-28
K833235	Kodak Multiloader II for X-Omatic Cass	Eastman Kodak Company			1983-10-28
K833234	Kodak T-Mat L Film So-387	Eastman Kodak Company	IWZ	Class I	1983-10-28
K833233	Hot Shot	Schiff Photo Mechanics	IYO	Class II	1983-10-28
K833228	Instant Imager	Schiff Photo Mechanics	JAK	Class II	1983-10-28
K833226	Pmx Mobile X-Ray System	Philips North America LLC	IZL	Class II	1983-10-28
K833199	Silicone Rubber Isolation Sleeve 350-01	Intermedics, Inc.	DXY	Class III	1983-10-28
K833197	Trach Swive/connector	Airlife, Inc.	BTR	Class II	1983-10-28
K833169	Mem W/l-Glutamine W/o Sodium Bicarbon	Sigma Chemical Co.	KIT	Class I	1983-10-28
K833168	Mem-Eagle-W/earles Salts W/neaa &	Sigma Chemical Co.	KIT	Class I	1983-10-28
K833166	Procedure 460 for Determ. of Chloride	Sigma Chemical Co.	CHJ	Class II	1983-10-28
K833165	Fishers Med. for Leukemic Cells-Mice	Sigma Chemical Co.	KIT	Class I	1983-10-28
K833163	Mem-Eagle W/earles Salts W/iveaa	Sigma Chemical Co.	KIT	Class I	1983-10-28
K833144	Rex Alloy	Jeneric Ind.	EJH	Class II	1983-10-28
K833088	Spirometer Isolation Valve #8890	Boehringer Mannheim Corp.	CAI	Class I	1983-10-28
K833073	Dahlberg #Uss in the Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1983-10-28
K833066	Dryden Mini Bacteria Filter	Dryden Corp.	CAH	Class II	1983-10-28
K833050	Rx 90	Jeneric Ind.	EJS	Class II	1983-10-28
K833049	Palladent	Jeneric Ind.	EJS	Class II	1983-10-28
K833027	Haemophilus/neisseria Identif-Panel	American Micro Scan			1983-10-28
K833003	Paramax Salicylate Reagent	American Dade	DKJ	Class II	1983-10-28
K832984	Disposa-Lite Laryngoscope Blade	Michael S. Upsher	CCW	Class I	1983-10-28
K832981	Electrodes for Blood Gas Analyzers	Analytical Products, Inc.	CHL	Class II	1983-10-28
K832962	Gas Chromatograph 5890A	Hewlett-Packard Co.	KZQ	Class I	1983-10-28
K832941	Bun Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	CDQ	Class II	1983-10-28