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 2003 of 3531

510(k) clearances, page 2003 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955748	Doyle Extractor	Safetech Intl., Inc.	FMI	Class II	1996-03-14
K954648	Femrx Operastar System	Gynecare Innovation Center	HIH	Class II	1996-03-14
K953773	6.5 Mhz Endorectal Convex Array (10R) Probe	Medison America, Inc.	IYO	Class II	1996-03-14
K953673	Eclipse Probe Cover	Parker Laboratories, Inc.	IYO	Class II	1996-03-14
K943843	Varicelisa, Modification	Biowhittaker Molecular Applications, Inc.	LFY	Class II	1996-03-14
K924313	Digital Conductance Meter	The Jayms Co.	HCC	Class II	1996-03-14
K960349	Permaridge Hydroxylapatite Matrix	Ceramed Corp.	FWP	Class II	1996-03-13
K960154	Psa Controls	Siemens Healthcare Diagnostics Inc.	JJX	Class I	1996-03-13
K960038	Spectrum Designs Silicone Block	Spectrum Designs, Inc.	MIB	Class II	1996-03-13
K955940	Total Bilirubin Reagent	Derma Media Lab., Inc.	CIG	Class II	1996-03-13
K955939	Calcium Reagent	Derma Media Lab., Inc.	CIC	Class II	1996-03-13
K955927	Bryan Posterior Spinal Fixator (Modification)	Arcan Orthopaedic Corp.	KWP	Class II	1996-03-13
K955884	Coordinate Revision Knee System	Depuy, Inc.	JWH	Class II	1996-03-13
K955863	Alldress Multi Layered Wound Dressing	Molnlycke/Scott Health Care	NAD	Class I	1996-03-13
K955781	Albumin	Derma Media Lab., Inc.	CIX	Class II	1996-03-13
K955761	Tibia Orthonail	Orthologic Corp.	HSB	Class II	1996-03-13
K955730	Ebi Anterior Cervical Spine System	Electro-Biology, Inc.	KWQ	Class II	1996-03-13
K955720	Amax Cs-190 Coagulation Analyzer System	Sigma Diagnostics, Inc.	JPA	Class II	1996-03-13
K955680	Shiley Cuffed Pediatric Tracheostomy Tube; Long Cuffed	Mallinckrodt Medical	JOH	Class II	1996-03-13
K955339	Hydrology 5000	Northgate Technologies Inc.	GBX	Class I	1996-03-13
K954952	Medrad/hitachi 1.5T Quad C-Spine Surface Coil	Medrad, Inc.	MOS	Class II	1996-03-13
K951193	Clinical Vital Signs Monitor, Model #52Stp-E1	Tycos Instruments, Inc.	DXN	Class II	1996-03-13
K943025	Freeman/samuelson Total Knee System	Zimmer GmbH	JWH	Class II	1996-03-13
K960797	D & K Sunglasses	D&K Stores, Inc.	HQY	Class I	1996-03-12
K960786	Fabris Lan Sunglasses	Fabris Lane Intl., Ltd.	HQY	Class I	1996-03-12
K960583	Matar General Purpose Disinfectant	Huntington Laboratories, Inc.	LRJ	Class I	1996-03-12
K960582	Ascend General Purpose Disinfectant	Huntington Laboratories, Inc.	LRJ	Class I	1996-03-12
K960580	Beaucoup General Purpose Disinfectant	Huntington Laboratories, Inc.	LRJ	Class I	1996-03-12
K960573	Sunglasses/eyeglass Frames	Architectures	HQY	Class I	1996-03-12
K960461	Sas Salmonella O Group R Factor 40 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-12
K960400	Diamond-Touch and Micro Diamond-Touch Instruments/diamond-Line Instruments/diamond-Port(access Parts)	Snowden-Pencer	FBM	Class I	1996-03-12
K960324	Hemagen Crp 150 Kit (Eia Method)	Hemagen Diagnostics, Inc.	DCK	Class II	1996-03-12
K960242	CPR Eye Tray	Custom Pack Reliability	KKX	Class II	1996-03-12
K960198	Digiscope Rx-2	Medirex, Inc.	OXO	Class II	1996-03-12
K960160	Sas Salmonella 0 Group M Factor 28 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-12
K960147	Sas Salmonella 0 Group E Factors 1,3,10,15,19,34 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-12
K960130	Sas Salmonella O Group Z Factor 50 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-12
K960129	Sas Salmonella O Group Y Factor 48 Antiserum	SA Scientific, Ltd	GRM	Class II	1996-03-12
K960081	Battery Powered Endosccopic Light Source	Mitsubishi Cable America, Inc.	FCQ	Class II	1996-03-12
K960052	Resound Personal Hearing System Bt2-Es, Bt2-Ev, & Bt241	Resound Corp.	ESD	Class I	1996-03-12
K960027	High Volume i.v. & Irrigation Tower	Allen Medical Systems, Inc.	FOX	Class I	1996-03-12
K955938	Creatinine Reagent	Derma Media Lab., Inc.	CGX	Class II	1996-03-12
K955937	Inorganic Phosphorus Reagent	Derma Media Lab., Inc.	CEO	Class I	1996-03-12
K955936	Total Protein Reagent	Derma Media Lab., Inc.	CEK	Class II	1996-03-12
K955872	Volmed Operation Drape	Medal Intl. Sales Co., LLC	KKX	Class II	1996-03-12
K955812	Syscon Turmor Marker Control	Scantibodies Laboratory Inc.	JJY	Class I	1996-03-12
K955785	Ts Percutaneous Arterial/venus Catheter Intro Set	C.R. Bard Inc	DYB	Class II	1996-03-12
K955724	Kc 1A Coagulation Analyzer/set	Sigma Diagnostics, Inc.	JPA	Class II	1996-03-12
K955679	Rns Sterile, Disposable Amniocentesis Tray	Contour Fabricators of Florida, Inc.	HIO	Class I	1996-03-12
K955657	North State Plastics Respiratory Mouthpiece	North State Plastics, Inc.	BYP	Class I	1996-03-12