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 2038 of 3531

510(k) clearances, page 2038 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K954518	Trebay Total Rectangular Head	Trebay Medical Corp.	ETA	Class II	1995-10-27
K954517	Trebay Partial Rectrangular Heads, Moretz Cam, Incus/stapedial Joint & Straight Incus Strut	Trebay Medical Corp.	ETB	Class II	1995-10-27
K954066	Miniscope Ms-3	Schiller America, Inc.	DPS	Class II	1995-10-27
K954008	Redi-Vu Systems (Send & Receive)	J.D. Technical Services	LMD	Class I	1995-10-27
K953884	Prophet	Qualitone	EWO	Class II	1995-10-27
K953684	Gsi 61 Clinical Audiometer	Grason-Stadler, Inc.	EWO	Class II	1995-10-27
K953640	Duna II Penile Prosthesis	Dacomed Corp.	FAE	Class II	1995-10-27
K953615	Forte Es-400	Chattanooga Group, Inc.	IPF	Class II	1995-10-27
K953614	Forte	Chattanooga Group, Inc.	IMG	Class II	1995-10-27
K953595	Magnetic Resonance Diagnostic Accessory	GE Healthcare	MOS	Class II	1995-10-27
K953553	Unscented Menstral Pad	Paragon Trade Brands, Inc.	HHD	Class I	1995-10-27
K953467	B-D Spinal Anesthesia Tray Spinal	BD Becton Dickinson Vacutainer Systems Preanalytic	CAZ	Class II	1995-10-27
K951463	Storz I/a Handpieces	Storz Instrument Co.	HQC	Class II	1995-10-27
K951373	Fuji Computed Radiography System Fcr9000hq, Fcr9501hq	FUJIFILM Healthcare Americas Corporation	IXW	Class II	1995-10-27
K951072	Protime Microcoagulation System	Accriva Diagnostics, Inc.	GKP	Class II	1995-10-27
K950869	Jc960 2 in 1 Eyeglass/contact Lens Case	Jobar Intl., Inc.	LRX	Class II	1995-10-27
K950783	4000+	U.S. Therapy Products, Inc.	IPF	Class II	1995-10-27
K950152	Chemmate(tm) Uchl1 (Cd45-Ro)	Biotek Solutions, Inc.	DFH	Class II	1995-10-27
K950150	Chemmate(tm) Kappa	Biotek Solutions, Inc.	DFH	Class II	1995-10-27
K945795	Eub-555A+	Hitachi Medical Corp. of America	IYO	Class II	1995-10-27
K942631	Electrocare	Waco Corp.	GZJ	Class II	1995-10-27
K942025	Burget Nasal Stent	Bivona Medical Technologies	LWF	Class I	1995-10-27
K936067	Atlas 1.0 Diagnostic Ultrasound System	Atlantis Diagnostics Intl., Inc.	IYN	Class II	1995-10-27
K954377	Forceps, Grasping, Flexible Endoscopic	Annex Medical, Inc.	FFL	Class II	1995-10-26
K954346	Chemstrip Micral Urine Test Strips	Boehringer Mannheim Corp.	JIR	Class I	1995-10-26
K954197	Disposable Flex Tube	Engstrom Medical	BZA	Class I	1995-10-26
K954072	Microsurge Puncture Close Device	Microsurge, Inc.	GCJ	Class II	1995-10-26
K954001	Spetzler Pin	Howmedica Corp.	HTY	Class II	1995-10-26
K953917	Lasesonics Low Power CO2 Laser System	Heraeus Surgical, Inc.	GEX	Class II	1995-10-26
K953848	Sas Salmonella O Group B Antigen	SA Scientific, Ltd	GNC	Class II	1995-10-26
K953846	Sas Salmonella O Group C Antigen	SA Scientific, Ltd	GNC	Class II	1995-10-26
K953844	Sas Salmonella VI Antigen	SA Scientific, Ltd	GNC	Class II	1995-10-26
K953843	Sas Salmonella O Group F Antigen	SA Scientific, Ltd	GNC	Class II	1995-10-26
K953842	Sas Salmonella H C Antigen	SA Scientific, Ltd	GNC	Class II	1995-10-26
K953841	Sas Salmonella O Group a Antigen	SA Scientific, Ltd	GNC	Class II	1995-10-26
K953534	Axsym Phencyclidine II	Abbott Medical	LCM	Unclassified	1995-10-26
K953517	Unscented Menstrual Pad	Paragon Trade Brands, Inc.	HHD	Class I	1995-10-26
K953511	Kendall Sheridan CPAP System	Kendall Healthcare Products Co. Div.Of Tyco Health	BYE	Class II	1995-10-26
K953485	Sims CPAP System	Smiths Industries Medical Systems, Inc.	BYE	Class II	1995-10-26
K953343	Needleless Injection Site	Medical Associates Network, Inc.	FPA	Class II	1995-10-26
K952806	Medi Pump Aspirator Models 1130 and 1135	Thomas Industries	BTA	Class II	1995-10-26
K952361	Abusign Doa 2, Doa, Coc/thc, Doa2, Biosign Doa2, Coc/thc	Princeton BioMeditech Corp.	DIO	Class II	1995-10-26
K951773	Podospray Drill System	Darco Intl., Inc.	GEY	Class I	1995-10-26
K951683	A-V Impulse System Model 6060	Novamedix, Ltd.	JOW	Class II	1995-10-26
K945585	Coman(r) Cu-11 Model Number 82-6634	Johnson & Johnson Professionals, Inc.	GWM	Class II	1995-10-26
K945549	Abusign(tm) Doa 4, Doa, Thc/opi/coc/amp or Met, Biosign(tm) Doa 4, Thc/opi/coc/amp or Met	Princeton BioMeditech Corp.	DIO	Class II	1995-10-26
K945120	Thymatron 2000 Electroconvulsive System	Somatics, LLC	QGH	Class II	1995-10-26
K944524	Snap Testing Device	Snap Laboratories, LLC	MNR	Class II	1995-10-26
K944463	Crw-1 System	Radionics Software Applications, Inc.	HAW	Class II	1995-10-26
K943872	Commander Mark II Hair Removal System	The Helene Edgar Corp.	KCX	Class I	1995-10-26