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 3365 of 3526

510(k) clearances, page 3365 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800328	Neisseria Gonorrhoeae Fluoro-Kit	Clinical Sciences, Inc.	GTH	Class II	1980-03-03
K800319	Alpha Detector	M.O.E Electronics Research & Prod.	HCC	Class II	1980-03-03
K800303	Electronic Perineometer	Associates in Biofeedback	HIR	Class II	1980-03-03
K800299	Ferritin Ria Kit	Amersham Corp.	DBF	Class II	1980-03-03
K800245	Emit Auto Cortisol Assay	Syva Co.	CGR	Class II	1980-03-03
K800242	Micro Medical Data System II	Micro/Tel., Inc.	JQP	Class I	1980-03-03
K800227	Ml-800 CO2	Merrimack Laboratories	HHR	Class II	1980-03-03
K800223	Patient Positioning System 1D or 2D	Laboratoire National D'Essais	IWE	Class I	1980-03-03
K800206	Aca Choleserol/hdl Cholesterol Calibrat.	E.I. Dupont de Nemours & Co., Inc.	JIS	Class II	1980-03-03
K800185	Sanitary Napkins Maxi-30	No Frills Discount Foods, Inc.	HHD	Class I	1980-03-03
K800160	Sun-Tanning Booths	World Wide Sun Systems, Inc.	FTC	Class II	1980-03-03
K800140	Silastic Scleral Sponge II W/circling Bd	Dow Corning Corp. Healthcare Industries Materials	HQX	Class II	1980-03-03
K800133	Panorex II Dental X-Ray Unit	Pennwalt Corp.	EHD	Class II	1980-03-03
K800089	Crawford Lacrimal Intubation Set	JEDMED Instrument Company	HNL	Class I	1980-03-03
K800063	Xr-710	Pennwalt Corp.	EAP	Class II	1980-03-03
K792559	Fiax Test Kit for Herpes Simplex Virus	Intl. Diagnostic Technology	GQL	Class II	1980-03-03
K792115	Biofeedback Devices & Accessories	M.O.E Electronics Research & Prod.	HCC	Class II	1980-03-03
K791330	Hysteroser	A. B. Vacuum Extractor, Inc.	HIH	Class II	1980-03-03
K800360	Output Digital Display Module, Mod. 611	Output, Inc.	DSK	Class II	1980-02-29
K800222	Model 412 Electrofluidic Manometer	Med-Tek Corp.	DXW	Class II	1980-02-29
K800214	Circamed I	Circadian, Inc.	DSH	Class II	1980-02-29
K800108	Bashaw Cervical Immobilizer Device	Bashaw Custom Specialties, Inc.	IQK	Class I	1980-02-29
K800066	Niastat	Invivo Research Labs, Inc.	DXN	Class II	1980-02-29
K792282	Drugalyzer Dtk-1000 Kit Presumptive Drug	California Medical Developments, Inc.	DKE	Class II	1980-02-29
K800386	Argyle Tru-Vol	Sherwood Medical Co.	BWF	Class II	1980-02-28
K800371	Will Ceram Lite-Cast B	Williams Gold Refining Co., Inc.	EJH	Class II	1980-02-28
K800369	Tri Pac Mouth Prop	Oxequip Health Ind.	JXL	Class II	1980-02-28
K800321	Concept Suction Coagulator	Concept, Inc.	KNS	Class II	1980-02-28
K800308	Pediatric Foley Catheter	Abco Dealers, Inc.	KOD	Class II	1980-02-28
K800307	Irrigation (3-Way) Foley Catheter	Abco Dealers, Inc.	KOD	Class II	1980-02-28
K800306	Foley Catheter	Abco Dealers, Inc.	KOD	Class II	1980-02-28
K800181	Dahlberg # Af Behing the Ear Hearing/aid	Dahlberg Electronics, Inc.	ESD	Class I	1980-02-28
K800149	Usci Sauvage Exs Vascular Prosthesis	C.R. Bard Inc	DSY	Class II	1980-02-28
K792726	Leukofix Poros	Beiersdorf, Inc.	FPX	Class I	1980-02-28
K800340	Phonic Ear, Model 841L	Hc Electronics	ESD	Class I	1980-02-26
K800325	Volu-Sol Histo./cyto. Stain Mod. #Ea65	Volu Sol Medical Industries	HZJ	Class I	1980-02-26
K800322	Volu-Sol Ea-50 Stain	Volu Sol Medical Industries	HZJ	Class I	1980-02-26
K800316	Oticon Model E19vf Earette Hearing Aid	Oticon, Inc.	ESD	Class I	1980-02-26
K800309	Specimen Collection Pan	Sage Products LLC	FMH	Class I	1980-02-26
K800289	Ldc Spectromonitor III	Laboratory Data Control	KIE	Class I	1980-02-26
K800284	Three-Way Stopcock Extension Set 20-Sl	Abbott Medical	FMG	Class II	1980-02-26
K800283	Oticon Model E17vf Earette Hearing Aid	Oticon, Inc.	ESD	Class I	1980-02-26
K800272	Rely Deoderant Tampon	Procter & Gamble Mfg. Co.	HIL	Class II	1980-02-26
K800271	Corometrics Medical Systems 220 Ph Sys.	Transidyne General Corp.	CHL	Class II	1980-02-26
K800270	Triex-2 Hollow Fiber Dialyzer	Extracorporeal Medical Specialities, Inc.	FJI	Class II	1980-02-26
K800269	Audionics Pb Max Hearing Aid	Audionics Corp.	ESD	Class I	1980-02-26
K800247	Emit -D.a.u. Cannabinoid Urine Calibs.	Syva Co.	DLJ	Class II	1980-02-26
K800246	Emit -D.a.u. Cannabinoid Urine Assay	Syva Co.	LAT	Class II	1980-02-26
K800241	Micro Medical Data System	Micro/Tel., Inc.	JQP	Class I	1980-02-26
K800235	Abco Connecting Tubes Precut Lengths	Abco Dealers, Inc.	BYY	Class II	1980-02-26