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 2168 of 3531

510(k) clearances, page 2168 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942746	Sucker Ends (Zoellner)	Exmoor Plastics Limited	LRC	Class I	1994-08-24
K942606	Surgical Staple	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1994-08-24
K942008	Interacoustics Automatic Impedance Audiometer	Precision Acoustics Ind., Inc.	ETY	Class II	1994-08-24
K942007	Interacoustics Clinical Impedance Audiometer Az26	Precision Acoustics Ind., Inc.	ETY	Class II	1994-08-24
K941985	Mueller Hinton Agar W/oxacillin	Carr-Scarborough Microbiologicals, Inc.	JTZ	Class II	1994-08-24
K941653	Sarns Turbo Membrane Oxygenator Modification	3M Health Care, Sarns	DTZ	Class II	1994-08-24
K935549	Gyrex 2T-Sgr	Elscint, Inc.	LNH	Class II	1994-08-24
K935026	Digital Media Converter (D-Mc)	Eigen Video	IZI	Class II	1994-08-24
K932771	Battery Powered, Disposable Endoscope Light Source	Xomed-Treace, Inc.	EQH	Class I	1994-08-24
K932168	Hexlock/hexlock Screw	Imtec Corp.	DZE	Class II	1994-08-24
K925079	Laparoscopic Inst. (Scissors,forceps,needleholder)	Endo Technic Corp.	HET	Class II	1994-08-24
K943700	Karl Storz Bronchoscope Accessories	Karl Storz Endoscopy-America, Inc.	EOQ	Class II	1994-08-23
K943578	Monoject High Volume/chemotherapy Sharps Container	Sherwood Medical Co.	FMI	Class II	1994-08-23
K943574	Capture Impression Material	Dentsply Intl.	ELW	Class II	1994-08-23
K943409	Side-Firing Urologic Refractive Fiber	Energy Life Systems Corp.	GEX	Class II	1994-08-23
K943373	Permagen F/dc	Ultradent Products Inc.	KLE	Class II	1994-08-23
K943339	Gauze Sponge (E.w.a. Ltd./various)	E.W.A., Ltd.	EFQ	Unclassified	1994-08-23
K943245	Spirit Mb	Sybron Dental Specialties, Inc.	DYW	Class II	1994-08-23
K942865	Laser Gas Mixture	Nordan Smith Welding Supplies	GEX	Class II	1994-08-23
K942819	Trocar with Shield	Mahe-Medizintechnik	GCJ	Class II	1994-08-23
K942740	Sharplan-Contec Ec-1000 Endoscopy Video Camera System	Sharplan Lasers, Inc.	GCJ	Class II	1994-08-23
K942727	Alpha Bound-Rite I No-Mix Adhesive or Bond-Rite I No-Mix Adhesive	Wallace A. Erickson & Co.	DYH	Class II	1994-08-23
K942623	Trimport	Gerard Medical Enterprises, Inc.	LJT	Class II	1994-08-23
K942531	Sunglasses	Lumen S.r.l.	HQY	Class I	1994-08-23
K942519	Uni-Syringe, Uni-Tip and Access Syringe Tips	Bull Frog Mfg. Co.	ECB	Class I	1994-08-23
K942488	Medcuff	Med-Con, Inc.	DXQ	Class II	1994-08-23
K942441	Imexdop CT+	Imex Medical Systems, Inc.	JAF	Class II	1994-08-23
K942212	Osteograf/ld-300 Hydroxylapatite	Ceramed Corp.	LYC	Class II	1994-08-23
K942076	Tongue Scraper	Maharishi Ayur-Ved	LCN	Class I	1994-08-23
K942054	Sharps-Tainer	Winfield Industries	FMI	Class II	1994-08-23
K941661	Gm Opti*cam Camer with Dental Fiber Optic Light	Gm Engineering, Inc.	EQH	Class I	1994-08-23
K941389	Empi Tape Patches	Empi	KGX	Class I	1994-08-23
K941299	Flared Patch	Flared Patch, Inc.	FTL	Class II	1994-08-23
K941027	Endopath Optical Obturator and Sleeve	Ethicon Endo-Surgery Inc	GCJ	Class II	1994-08-23
K940796	Access	Toshiba America Mri, Inc.	LNH	Class II	1994-08-23
K940750	Innervision,inc. Laparoscopic Electrodes	Innervision, Inc.	GEI	Class II	1994-08-23
K940606	Hispeed Advantage II	GE Healthcare	JAK	Class II	1994-08-23
K940392	Peregrine Pic Minipulator	Peregrine Surgical, LLC.	KYG	Class I	1994-08-23
K935889	Occlufast	Zhermack Dental Production	ELW	Class II	1994-08-23
K935888	Elite Fast Light Body	Zhermack Dental Production	ELW	Class II	1994-08-23
K935887	Elite Regular Body	Zhermack Dental Production	ELW	Class II	1994-08-23
K935886	Elite Light Body	Zhermack Dental Production	ELW	Class II	1994-08-23
K935885	Elite Fast Putty Soft	Zhermack Dental Production	ELW	Class II	1994-08-23
K935884	Elite Putty Soft	Zhermack Dental Production	ELW	Class II	1994-08-23
K935631	Conbio Medalex Laser System	Continuum Biomedical, Inc.	GEX	Class II	1994-08-23
K934831	Advanced Automatic Kv	Elscint, Inc.	IZH	Class II	1994-08-23
K931242	Elite Putty Hard	Zhermack Dental Production	ELW	Class II	1994-08-23
K926005	Fresenius Hemoflow, Various Models	Fresenius USA, Inc.	FJI	Class II	1994-08-23
K922553	Cla-Computerized Laryngeal Analyzer	H.I.L. Research, Ltd.	KLA	Class II	1994-08-23
K943823	Fuji Fg Series Intensifying Screens: Fg-3-4-8-12	FUJIFILM Healthcare Americas Corporation	EAM	Class I	1994-08-22