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 1847 of 3531

510(k) clearances, page 1847 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964819	Sheng Ho	Shang HO Industrial Corp., Ltd.	LYY	Class I	1998-01-06
K974647	Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633	Customed, Inc	KKX	Class II	1998-01-05
K974443	Powder Free Nitrile Examination Gloves - Polymer Coated	P.T. Latexindo Tobaperkasa	LYZ	Class I	1998-01-05
K974442	Pre-Powdered Nitrile Examination Gloves	P.T. Latexindo Tobaperkasa	LZY	Class II	1998-01-05
K974140	Adhesive Hybrid Ionomer Cement	Dentsply Intl.	EMA	Class II	1998-01-05
K973926	O Butment Hs Implant	O Co., Inc.	DZE	Class II	1998-01-05
K973851	Alexander Manufacturing Co. Rechargeable Battery #M12/630	Alexander Mfg. Co.	FRN	Class II	1998-01-05
K973845	Cordis Hydronol Steerable Guidewire	Cordis US Corp.	DQX	Class II	1998-01-05
K973828	Prima Ktp Laser System	Nidek, Inc.	GEX	Class II	1998-01-05
K973810	Drg Large Screw System	Dolphin Medical Technologies, Inc.	HWC	Class II	1998-01-05
K972971	Npg + 2	Aalba Dent, Inc.	EJH	Class II	1998-01-05
K971366	Incuwarmer	Hill-Rom Inc.	FMT	Class II	1998-01-05
K970648	Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350s,2000,2000s)	Renal Systems, Inc.	MSF	Class II	1998-01-05
K974634	Immulite Free T3	Siemens Healthcare Diagnostics Inc.	CDP	Class II	1998-01-02
K974620	Ammonia-Incorporating Dynamic Stabilization Technology (Dst)	Trace America, Inc.	JIF	Class I	1998-01-02
K974512	Aimstick Pbd Combo Pregnancy	Germaine Laboratories, Inc.	DHA	Class II	1998-01-02
K974374	Safe Needle Direct Blood Transfer Device, Model Ta-Stv	GE Healthcare	JKA	Class II	1998-01-02
K974368	Aimstick Pbd Pregnancy	Germaine Laboratories, Inc.	DHA	Class II	1998-01-02
K973890	Universalplus Laparoscopic Abc/electrosurgical Electrode	Conmedcorp	GEI	Class II	1998-01-02
K973863	Memorytrace Model 4224 Ambulatory ECG Monitor	Hi-Tronics Designs, Inc.	DXH	Class II	1998-01-02
K973809	Foundation Fracture Stem	Encore Orthopedics, Inc.	JDI	Class II	1998-01-02
K973805	Imageaccess System	Storcomm, Inc.	LMD	Class I	1998-01-02
K973799	Cardiac Tagging Techniques/magnetom Vision and Magnetom Impact	Siemens Medical Solutions USA, Inc.	LNH	Class II	1998-01-02
K973796	S-41 &41S Video Imaging System	Sopro	GCJ	Class II	1998-01-02
K973795	S-52 Electronic Video Laparoscope	Sopro	GCJ	Class II	1998-01-02
K973794	S-57 Video Imaging System	Sopro	GCJ	Class II	1998-01-02
K973786	Northwest Radiation Therapy Products, Precision Stepper and Guide	Nw Radiation Therapy Products	IWJ	Class I	1998-01-02
K973651	Stc Cocaine Metabolite Micro-Plate Eia	OraSure Technologies, Inc.	DIO	Class II	1998-01-02
K973457	Chromalex E. Coli 0157 Latex Test System, Prod. No. 800	Shared Systems, Inc.	GMZ	Class I	1998-01-02
K973040	Spife Ife-6	Helena Laboratories, Corp.	CFF	Class II	1998-01-02
K972701	Barco Mwd 321 Medical Workstation Display	Barco NV Display Systems	LMD	Class I	1998-01-02
K971653	Glucochek Pocketlab II Blood Glucose System	Clinical Diagnostics, Inc.	CGA	Class II	1998-01-02
K971304	Quanta Lite Rebella Igg	Inova Diagnostics, Inc.	LFX	Class II	1998-01-02
K970629	Tango Non-Invasive Blood Pressure Monitor	Suntech Medical Instruments, Inc.	DXN	Class II	1998-01-02
K973764	Temperature Diagnostic Accessory	New Star Lasers, Inc.	GEX	Class II	1997-12-31
K973763	Kendall Curity Iodoform Packing Strip	Kendall Healthcare Products Co. Div.Of Tyco Health	EFQ	Unclassified	1997-12-31
K973833	Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing Diagnostic, Beam Limiting Device, Manual	Dynarad Corp.	IZL	Class II	1997-12-30
K973787	Medrad 1.5T Extremity Array	Medrad, Inc.	MOS	Class II	1997-12-30
K971696	Sentinel Recorder, Models 471/472	Del Mar Avionics	DXH	Class II	1997-12-30
K971663	Wellcolex E.coli O157:h7	Murex Biotech, Ltd.	GMZ	Class I	1997-12-30
K955893	Everytime Transfucer Cover	Amedic AB	ITX	Class II	1997-12-30
K973873	Digital Personal Telemedicine Module, Digital Ptm 1	American Telecare, Inc.	DRG	Class II	1997-12-29
K973862	Port-a-Cath Low-Profile Implantable Access Systems	Sims Deltec, Inc.	LJT	Class II	1997-12-29
K973857	Flostat Vascular Report Generator (Vrg)	Biomedix Wai	JAF	Class II	1997-12-29
K973806	Duoderm Hydroactive Gel	Convatec, A Bristol-Myers Squibb Co.	MGQ	Unclassified	1997-12-29
K973774	Codman Hakim Micro Precision Valve	Johnson & Johnson Professionals, Inc.	JXG	Class II	1997-12-29
K973744	Unicath Sp Bi-Plane (Model M269 & M289)	Xre Corp.	JAA	Class II	1997-12-29
K973736	Aesculap Hilan Motor System	Aesculap Inc	HWE	Class I	1997-12-29
K972258	Hi-Care Closed Suction System	Mallinckrodt Medical	BSY	Class I	1997-12-29
K971775	Interim Av Shaped Temporary Pacing Catheter Model Int-Av610	Cardiac Control Systems, Inc.	LDF	Class II	1997-12-29