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 2375 of 3531

510(k) clearances, page 2375 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915211	Microchamber	Respiratory Delivery Systems, Inc.	CAF	Class II	1992-05-20
K914987	High Pressure Connecting Sets, Modification	E-Z-EM, Inc	DTL	Class II	1992-05-20
K914986	Guide Wires, Modification	E-Z-EM, Inc	DQX	Class II	1992-05-20
K914984	E-Z-Flow Angiography Catheters, Modification	E-Z-EM, Inc	DQY	Class II	1992-05-20
K914754	Medtronic Bio-Medicus Bio-Console Model 540-D	Medtronic Bio-Medicus, Inc.	DWA	Class II	1992-05-20
K913395	Ez-1 System Respiratory Effort Sensors	Pro-Tech, Inc.	BZG	Class II	1992-05-20
K913181	Autologous Blood Processing System	Lifestream Int'L, Inc.	CAC	Class II	1992-05-20
K921775	Spyroflex Wound Closures	Polymint Industrial Co., Ltd.	FPX	Class I	1992-05-19
K920307	Ausonics Opus 1 System, Annular Array Option	Ausonics Pty, Ltd.	ITX	Class II	1992-05-19
K922066	Telex Model 28A Ite Custom Hearing Aid	Telex Communications, Inc.	ESD	Class I	1992-05-18
K922065	Telex Model M29 Ite Custom Hearing Aid	Telex Communications, Inc.	ESD	Class I	1992-05-18
K921278	M-2000 Diagnostic and Teleradiology Workstation	Metecon, Inc.	LMD	Class I	1992-05-18
K921255	Philips Bv26 Mobile C-Arm Stand	Philips North America LLC	OXO	Class II	1992-05-18
K920756	Feldmuhle Ceramic Head	Link America, Inc.	LZO	Class II	1992-05-18
K920718	Disposable Posterior Microscissors	Storz Instrument Co.	HQE	Class II	1992-05-18
K915412	Hysteroscopic Myoma Screw	Cook Incorporated	HHO	Class II	1992-05-18
K915388	Laparocopic Myoma Screw	Cook Incorporated	HHO	Class II	1992-05-18
K914589	Sabratek 3030 Infusion Pump	Sabratek Corp.	FRN	Class II	1992-05-18
K904581	Sporicidin Brand Disinfectant Solution	Sporicidin Intl.	LRJ	Class I	1992-05-18
K904580	Sporicidin Brand Disinfectant Spray	Sporicidin Intl.	LRJ	Class I	1992-05-18
K904579	Sporicidin Brand Disinfectant Towelettes	Sporicidin Intl.	LRJ	Class I	1992-05-18
K921501	Deluxe C Arm Radiological Table, Model #056-004	Biodan Medical Systems, Ltd.	IZZ	Class II	1992-05-15
K921257	Eurion Lotos P Hearing Aid	Manro Corp.	ESD	Class I	1992-05-15
K921191	Gianturco-Rosch Biliary Z Stent	Cook Inc.	FGE	Class II	1992-05-15
K921101	Philips Integris V3000 Film	Philips North America LLC	IZI	Class II	1992-05-15
K921098	Magnetom 63Sp	Siemens Medical Solutions USA, Inc.	LNH	Class II	1992-05-15
K921085	Programmed Audiometric Device (Pad)/recors (Par)	Hear-Well Technologies, Inc.	EWO	Class II	1992-05-15
K920994	Hood Nasal Septal Button	Hood Laboratories	LFB	Unclassified	1992-05-15
K920988	Atmos Mirror Warmer	JEDMED Instrument Company	LRC	Class I	1992-05-15
K920949	Software Modification for Miles H*1 S/w Ver. 1.5	Kulzer GmbH	GKZ	Class II	1992-05-15
K920842	Aerosol Delivery Systems	Hospitak, Inc.	LRD	Class I	1992-05-15
K920577	Howedica Zirconia Femoral Head	Howmedica Corp.	LZO	Class II	1992-05-15
K920524	Osteonics 7000 Series Total Knee Bone Augmentation	Osteonics Corp.	JWH	Class II	1992-05-15
K920094	Magnetic Resonance Diagnostic Device Accessories	Siemens Medical Solutions USA, Inc.	LNH	Class II	1992-05-15
K915828	Injection Site with Luer Lock	Baxter Healthcare Corporation	FPA	Class II	1992-05-15
K915567	Magnetic Resonance Diagnostic Device(accesory)	Fonar Corp.	LNH	Class II	1992-05-15
K915202	Internal Modem for the E560 Electrocardiograph	Siemens Burdick, Inc.	LOS		1992-05-15
K914565	Osteonics 7000 Posterior Stab. Total Knee Fem. Com	Osteonics Corp.	JWH	Class II	1992-05-15
K913209	Accessory to Genesis III (Gcfm)	Biosound, Inc.	DXK	Class II	1992-05-15
K910625	Ultracalm	Sion Technology, Inc.	LWM	Unclassified	1992-05-15
K921629	N-Tact(r) Pth Sp Kit	Incstar Corp.	CEW	Class II	1992-05-14
K920206	Posey Sitter	J. T. Posey Co.	KMI	Class I	1992-05-14
K920058	Supergloves	Sempermed Glove Industries Sdn Bhd	LYY	Class I	1992-05-14
K920004	Pbi Multilase D Copper Vapor Laser	Wm.I.Kern & Co., Inc.	GEX	Class II	1992-05-14
K915560	Lo-Profile Extension Set	Douglas Medical Products, Inc	FPK	Class II	1992-05-14
K915066	Disposable Skin Marker	American Medical Mfg., Inc.	FZZ	Class I	1992-05-14
K914955	K-Defib/pace Electrode	Katecho LLC	DRO	Class II	1992-05-14
K914941	Simon Breast Lesion Localization Needle	Argon Medical Devices, Inc	GDF	Class I	1992-05-14
K921646	Nextec Fiberoptic Illuminator 300 Watt Xenon	Nextec Corp.	FST	Class II	1992-05-13
K921625	Calcium-Arsenazo III Reagent Set	Horiba Instruments Incorporated	CIC	Class II	1992-05-13