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 1982 of 3531

510(k) clearances, page 1982 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960546	Clinitek 50 Urine Chemistry Analyzer	Bayer Corp.	KQO	Class I	1996-06-12
K953680	First Choice Glucose & Ketones Urine Test Strips	Polymer Technology Intl.	JIN	Class I	1996-06-12
K935024	Esi-5000	Elscint, Inc.	IYN	Class II	1996-06-12
K962004	Aq Hydrophilic Urological Catheters	Cook Incorporated	EYB	Class II	1996-06-11
K961945	Tympanostomy Ventilation Tube	Advanced Microbotics Corp.	ETD	Class II	1996-06-11
K961828	Liquichek Cardiac Markers Control (Cat. No. 685,686,687,688)	Bio-Rad	JJT	Class I	1996-06-11
K961822	Wet-Prep	Bisco, Inc.	KLE	Class II	1996-06-11
K961501	Elecsys Ck-Mb	Boehringer Mannheim Corp.	JHW	Class II	1996-06-11
K961500	Elecsys Troponin T	Boehringer Mannheim Corp.	MMI	Class II	1996-06-11
K961489	Elecsys Ft4 Assay	Boehringer Mannheim Corp.	CEC	Class II	1996-06-11
K961301	E-Scope Electronic Stethoscope Model 718-7120	Delphi Consulting Group	DQD	Class II	1996-06-11
K961160	Upacs Version 1.7	Base Ten Systems, Inc.	LMB	Class I	1996-06-11
K961070	Esophageal Manometry Analysis Module	Synectics Medical, Inc.	KLA	Class II	1996-06-11
K961040	Blood Port Cap, Dialysate Port Cap, Red Hard Plastic	Dayspring Medical, Inc.	FJI	Class II	1996-06-11
K955104	High Flow Adjustable Entrainment Nebulizer	Automatic Liquid Packaging, Inc.	CAF	Class II	1996-06-11
K961879	Electronic Thermometer	Wiltec Industries, Ltd.	FLL	Class II	1996-06-10
K961714	Aseptylum, Uni-Carrier	Distriflor S.A.	EKJ	Class I	1996-06-10
K961574	Tongue Scrapper	U.S. Dentek Corp.	LCN	Class I	1996-06-10
K961309	Pos-T-Vac Id-300	Pos-T-Vac, LLC	KZH	Class II	1996-06-10
K961227	Jj Skinner Carekits Wound Care Management/dressing Change Tray	J.J. Skinner, Inc.	FRG	Class II	1996-06-10
K961026	Blood Port Cap, Luer-Lock Fitting, Dayspring Medical Part No. Bpc252ll	Dayspring Medical, Inc.	FJI	Class II	1996-06-10
K955947	Ostar Examination Gloves	Contract Latex Dippers Sdn Bhd	LYY	Class I	1996-06-10
K955634	Montgomery Tracheostomy Speaking Valve	Boston Medical Products, Inc.	CBP	Class II	1996-06-10
K955529	Crytron System	Mark H. Friedman	ILO	Class II	1996-06-10
K955424	Ostar	Ultravena Industries, Ltd.	LYY	Class I	1996-06-10
K955389	Mr Guided Procedures Package/magnetom Open System	Siemens Medical Solutions USA, Inc.	LNH	Class II	1996-06-10
K952513	Lese Stents Sets	Cook Incorporated	FAD	Class II	1996-06-10
K936135	Sudormed Sweat Patch Specimen Container for Collection of Marijuana in Perspiration	Sudormed, Inc.	LAT	Class II	1996-06-10
K961623	Facscomp Software & Calibrite 3 Color Beads Kit/calibrite Percp Beads	Becton Dickinson Monoclonal Center	GKZ	Class II	1996-06-07
K961395	Medi-Trace Radiolucent	Graphic Controls Corp.	DRX	Class II	1996-06-07
K961300	Aspiration/irrigation Catheter	Neuro Navigational Corp.	GWG	Class II	1996-06-07
K961173	1.2Mm Reusable Neuroview Endoscope	Neuro Navigational Corp.	GWG	Class II	1996-06-07
K960981	Kodak Digital Science(kds) Medical Image and Information Library	Kodak Health Imaging Systems, Inc.	LMB	Class I	1996-06-07
K960183	Flexsure Hp,controls for Flexsurehp,flexpack Hp(abbott Diagnostics)andcontrols for Flexpack Hp (Abbott Diagnostics)	Smithkline Diagnostics, Inc.	LYR	Class I	1996-06-07
K960025	Protek Low Profile Acetabular Cup	Intermedics Orthopedics	JDI	Class II	1996-06-07
K955345	Lmd Cryptosporidium Antigen Detection	Lmd Laboratories	MHJ	Class II	1996-06-07
K955132	Heartport Endoaortic Clamp	Heartport, Inc.	DXC	Class II	1996-06-07
K955059	Olympus Comm. Ntwk., Sc 3000 Wkst. & Remote Display, R 100 Recorder	Siemens Medical Solutions USA, Inc.	DSI	Class II	1996-06-07
K954774	Shielded Trocar (Obturator)	Gabris Surgical Corp.	HET	Class II	1996-06-07
K953690	Cls Stem (Modification)	Intermedics Orthopedics	LZO	Class II	1996-06-07
K952054	Siemens Sirecust Monitoring (1200, 1200 Neo, 960)	Siemens Medical Solutions USA, Inc.	DSI	Class II	1996-06-07
K951821	Cytomegalovirus Direct Immunofluorescence Assay	Light Diagnostics	LIN	Class II	1996-06-07
K951709	Mardx Lyme Disease (Igm) Marblot Strip Test System	Mardx Diagnostics, Inc.	LSR	Class II	1996-06-07
K961990	Non-Prescription Sunglasses	Rokko Stars Co., Ltd.	HQY	Class I	1996-06-06
K961527	Mx703 and Mx730 Continuous Flush Devices	Medex, Inc.	KRA	Class II	1996-06-06
K961154	Baxter Sodium Acetate Infant Heel Warmer	Baxter Healthcare Corporation	MPO	Class I	1996-06-06
K961061	Codi Synthetic Sponge(non-Sterile and Sterile)	Codi International BV	EFQ	Unclassified	1996-06-06
K961056	Bioview Model S960000	Diversatek Healthcare Inc	KLA	Class II	1996-06-06
K961051	Universal Total Wrist System (Modification)	Kinetikos Medical, Inc.	JWJ	Class II	1996-06-06
K960704	Depuy M. Kurosaka Advange Mangnum Rev. Interference Screws	Depuy, Inc.	HWC	Class II	1996-06-06