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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2206 of 3531

510(k) clearances, page 2206 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940873	Safetex Hypoallergenic Powderfree Latex Examination Glove	Aladan Corp.	LYY	Class I	1994-04-22
K940758	Compel Surgical Gowns	Standard Textile Co., Inc.	FYA	Class II	1994-04-22
K940309	X-Ray Grid (Radiological Grid)	J.P.I. Chicago Co.	IXJ	Class I	1994-04-22
K934559	Karl Storz Xenon Light Source Model 201320-20	Karl Storz Endoscopy-America, Inc.	GCT	Class II	1994-04-22
K933806	Monopolar EMG Needle Electrode	Cadwell Laboratories, Inc.	GXZ	Class II	1994-04-22
K933798	Nu-Prep Gel	Cadwell Laboratories, Inc.	GXB	Class I	1994-04-22
K933795	Concentric EMG Needle Electrode	Cadwell Laboratories, Inc.	GXZ	Class II	1994-04-22
K925822	Custom Syrigene Kits	Syrigene Medical Technologies, Inc.	FMF	Class II	1994-04-22
K923372	Memory Wire	Althan, Inc.	EJF	Class I	1994-04-22
K922911	Options Comfort Curves Cloth Menstrual Pad System	Feminine Options	HHD	Class I	1994-04-22
K941217	Dupaque Sponge	Dumex Medical Surgical Products, Ltd.	GDY	Class I	1994-04-21
K940571	Synermedir Cal I and Synermed Ir Cal II	Synermed, Inc.	JIX	Class II	1994-04-21
K940543	Model 777 Therapeutic Massager	Voyager Medical Corp.	ISA	Class I	1994-04-21
K940466	Titanium Bipolar Forceps	Radionics, Inc.	GEI	Class II	1994-04-21
K940369	Body Recharger	Conair LLC.	ISA	Class I	1994-04-21
K940353	Beckman Beta-2-Microglobulin (B2m)	Beckman Instruments, Inc.	JZG	Class II	1994-04-21
K940074	Y-Type Blood Administration Set	Puritas Health Care, Inc.	BRZ	Class II	1994-04-21
K936148	Stress Handler	Arocep Enterprises, Ltd.	LYG	Class I	1994-04-21
K936034	Serim Pyloritek Reagent Strips	Serim Research Corp.	JTO	Class I	1994-04-21
K935763	Surgipump	Novanta Medical GmbH	DQI	Class II	1994-04-21
K935756	Endoscopic Articulating Multi-Feed Stapler with Reload Unit	Ethicon Endo-Surgery Inc	OCW	Class II	1994-04-21
K935667	Qtest(r) Strep	Becton Dickinson Advanced Diagnostics	GTY	Class I	1994-04-21
K935618	Specimen Transport Medium	Biowhittaker Molecular Applications, Inc.	JSM	Class I	1994-04-21
K935367	Tava Wire-Driver	Tava Surgical Instruments	HSZ	Class I	1994-04-21
K935325	A-Dec Cascade 3072 Wallmount	A-dec, Inc.	EIA	Class I	1994-04-21
K935207	Endoflush System 1.0, 2.O, 3.0	Specialty Medical Systems, Inc.	GCJ	Class II	1994-04-21
K934594	Magic Lite Sq Specific Ige Immunoassay System	Ciba Corning Diagnostics Corp.	DGC	Class II	1994-04-21
K934324	Ot Igg Sorbent	bioMerieux, Inc.	DEW	Class II	1994-04-21
K934069	Millex, Dualex (Plus, Ultra)	EMD Millipore Corporation	FIB	Class II	1994-04-21
K933576	Arthroscope, Disposable	United States Surgical, A Division of Tyco Healthc	HRX	Class II	1994-04-21
K933245	Ultraline II Sterile Disposable Fiber	Heraeus Lasersonics, Inc.	GEX	Class II	1994-04-21
K932456	Jarit Surgical Instruments	J. Jamner Surgical Instruments, Inc.	KNF	Class II	1994-04-21
K931756	Quantikine(tm) Erythropoietin Human Serum Controls	R & D Systems, Inc.	GGT	Class II	1994-04-21
K925493	Biomerieux Hemolab Thrombicalci-Test	Biomerieux Vitek, Inc.	GJA	Class II	1994-04-21
K924892	Fibrinostika(r) Fgdp Microelisa System	bioMerieux, Inc.	DAT	Class II	1994-04-21
K922154	Insulated Speculum W/ Smoke Evacuator Option	Olsen Electrosurgical, Inc.	HIB	Class II	1994-04-21
K940900	Appendix Extractor 8385.50	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-04-20
K940588	Enzyme Immunoassay Anti-Sm/rnp Antibody Test Kit	Helix Diagnostics, Inc.	LKO	Class II	1994-04-20
K940574	Tenderbrede(r) Packing and Debridement Sponge	Kendall Healthcare Products Co. Div.Of Tyco Health	EFQ	Unclassified	1994-04-20
K940570	Synermed Total Bilirubin Reagent Kit	Synermed, Inc.	CIG	Class II	1994-04-20
K940510	Enzyme Immunoassay Anti-Sm Antibody Test Kit	Helix Diagnostics, Inc.	LKP	Class II	1994-04-20
K940310	Helena Thromboplastin-Mi Reagent	Helena Laboratories, Corp.	GJS	Class II	1994-04-20
K940272	Acs Normal Angiotensin Converting Enzyme Control	Analytical Control Systems	JJX	Class I	1994-04-20
K940270	Lci-100 and Lci-200 Welch Allyn Illumination and Imaging System	Welch Allyn Inc	GCT	Class II	1994-04-20
K935828	Hemagen Ena Screen-6 Kit (Eia Method)	Hemagen Diagnostics, Inc.	LLL	Class II	1994-04-20
K935158	Kacey Disposable Glove Liner	K & C Medical, Inc.	LYU	Class I	1994-04-20
K934774	Unknown	Granbio, Inc.	LSE	Class I	1994-04-20
K933457	Rim E.coli 0157:H7 Latex Test	Remel Inc	GNA	Class I	1994-04-20
K923792	Quantec Spinal Measuement System	Quantec Image Processing, Ltd.	LDK	Unclassified	1994-04-20
K921456	Fresenius 3008/Fds-08 Dialysate Delivery System	Fresenius USA, Inc.	FKP	Class II	1994-04-20