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 3369 of 3526

510(k) clearances, page 3369 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800070	Glucose Oxidase Reagent Kit	Fisher Scientific Company L.L.C.	CGA	Class II	1980-02-05
K800068	Electrical Muscle Stimulator (Ems)	Staodynamics, Inc.	IPF	Class II	1980-02-05
K800065	Asi Reagent	Gilford Diagnostics	CIT	Class II	1980-02-05
K800054	Kodak Ektachem Electrolyte Analyzer	Eastman Kodak Company	CEM	Class II	1980-02-05
K800037	Platelet Retention (Adhesion) Columns	Hemometrix	JBZ	Class II	1980-02-05
K800031	Permadyne Polyether Rubber Impression	Espe Dental Products	ELW	Class II	1980-02-05
K792619	Rmc Knee Metal Shoe Tibial Components	Richard'S Medical Equip., Inc.	HRY	Class II	1980-02-05
K792565	Sorin Pulse Generator Model # Lit 214 H	Bentley Laboratories, Inc.	DXY	Class III	1980-02-05
K792526	Pulse Generator, Model No. Lit 222	Bentley Laboratories, Inc.	DXY	Class III	1980-02-05
K792492	Uca Gel	Vanaray Laboratories, Inc.	IYO	Class II	1980-02-05
K792491	Eca Cream	Vanaray Laboratories, Inc.	GYB	Class II	1980-02-05
K792489	Uca Cream	Vanaray Laboratories, Inc.	IYO	Class II	1980-02-05
K792488	Eca Gel	Vanaray Laboratories, Inc.	GYB	Class II	1980-02-05
K792459	Pneupac Ventilator/resuscitator	Pneupac, Ltd.	CBK	Class II	1980-02-05
K792458	Pneupac Test Set, Pt.#500-A250	Pneupac, Ltd.	DRM	Class II	1980-02-05
K792457	Compressor	Pneupac, Ltd.	BTI	Class II	1980-02-05
K792456	Pneupac Ventilator/resuscitator #3	Pneupac, Ltd.	CBK	Class II	1980-02-05
K792455	Pneupac Ventilator/resuscitator #2	Pneupac, Ltd.	CBK	Class II	1980-02-05
K792454	Pneupac Resuscitator Instant Action Set	Pneupac, Ltd.	DRM	Class II	1980-02-05
K792453	Pneupac Oxygen Therapy Unit	Pneupac, Ltd.	BTL	Class II	1980-02-05
K792452	Pneupac Resuscitator Instant Action Set	Pneupac, Ltd.	DRM	Class II	1980-02-05
K792451	Pneupac Resuscitator Instant Action Set	Pneupac, Ltd.	DRM	Class II	1980-02-05
K792418	Sharplan 743, CO2 Laser Surgical System	Laser Industries, Ltd.	GEX	Class II	1980-02-05
K792269	Wright Dow Corning Softgoods W/dow	Dow Corning Wright	IPY	Class I	1980-02-05
K800171	Diagnostic Intravascular Catheter	Flomed, Inc.	DQO	Class II	1980-02-01
K800135	Cardioplegia Administration System Cas	Bentley Laboratories, Inc.	KRJ	Class II	1980-02-01
K800122	Hancock Aortic Punch	Hancock Laboratories, Inc.	DWS	Class I	1980-02-01
K800025	Dinamap Research Monitor 1245	Applied Medical Research	DXN	Class II	1980-02-01
K800003	Cortex Double Helix Sampler	Cortex Research Corp.	GLE	Class I	1980-02-01
K792696	Micropitette	Meridian Diagnostics, Inc.	JRC	Class I	1980-02-01
K792541	Monoject Plastic Dental Inj. Syringe	Sherwood Medical Co.	EJI	Class II	1980-02-01
K791798	Conphar Surgical Razorr	Conphar, Inc.	LDQ		1980-02-01
K800168	H-H Fifth Ventricle	Holter-Hausner Intl.	JXG	Class II	1980-01-31
K800027	Microthin-Pi	Cardiac Pacemakers, Inc.	DXY	Class III	1980-01-31
K800026	Microthin-Di	Cardiac Pacemakers, Inc.	DXY	Class III	1980-01-31
K800001	Mini-Cears Computer (Model 1)	Bik Foundation, Inc.	GWS	Class I	1980-01-31
K792536	Cynergy Model 182	Cynergy	DTE	Class II	1980-01-31
K792371	Telemetry System Xmt-1 & Rec-1	Burdick Corp.	GYE	Class II	1980-01-31
K791975	Pacing System Analyzer Psa Sce-22	Ela Medical, Inc.	DTC	Class II	1980-01-31
K800088	Pacemaker Electrode Inserter Aide	Telectronics, Inc.	DTE	Class II	1980-01-29
K800084	Ritter Model J Dental Chair	Ritter GmbH	KLC	Class I	1980-01-29
K800055	H-I-M-Test for Detecting Human Chor. Gon	Technam, Inc.	JHJ	Class II	1980-01-29
K800048	Ldc Constametric III Hight Press. Sol.	Laboratory Data Control	KIE	Class I	1980-01-29
K800024	i.v. Tape Down Holder	Consolidated Medical Equipment Company	KMK	Class I	1980-01-29
K800012	Rionet Hearing Aid Ha-61	Rion Acoustic Instruments, Inc.	ESD	Class I	1980-01-29
K800011	Rionet Hearing Aid He-71	Rion Acoustic Instruments, Inc.	ESD	Class I	1980-01-29
K792668	Coulter Counter-Blood Cell Counter	Coulter Electronics, Inc.	GKL	Class II	1980-01-29
K792665	Pixie	Porta Ray, Inc.	IZL	Class II	1980-01-29
K792660	1500 Eo Exhaust Hood	Castle Co.	FLF	Class II	1980-01-29
K792649	Unispore-Biological Indicators	Castle Co.	FRC	Class II	1980-01-29