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 1883 of 3531

510(k) clearances, page 1883 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K971854	Osteolock Acetabular Shell System	Howmedica Corp.	LPH	Class II	1997-07-30
K971802	Vaginal Suturing Kit for Bladder Neck Suspension	Louisville Laboratories, Inc.	MBI	Class II	1997-07-30
K971800	Osteo Cannulated Screw System	Osteonics Corp.	HWC	Class II	1997-07-30
K971791	Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension	Louisville Laboratories, Inc.	MBI	Class II	1997-07-30
K971752	Zirconia Ceramic Femoral Head (12/14 Taper)	Zimmer GmbH	LZO	Class II	1997-07-30
K971723	Fastak Suture Anchor (11.7Mm)/(7.5mm)	Arthrex GmbH	MBI	Class II	1997-07-30
K971721	Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head	Whiteside Biomechanics, Inc.	LZO	Class II	1997-07-30
K970793	Implantable Clip	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1997-07-30
K964282	Tina-Quant Ferritin Assay	Boehringer Mannheim Corp.	JMG	Class II	1997-07-30
K963780	Dual Rod Anterior Fixator System	Sofamor Danek USA,Inc.	KWQ	Class II	1997-07-30
K955668	Intracavity Needle Guide Kit	Arlanda Medicinska Instrument Co. AB	ITX	Class II	1997-07-30
K972672	Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment Accessory	Barzell-Whitmore Maroon Bells, Inc.	ITX	Class II	1997-07-29
K972373	Ovation Hdp	Orsonique, Inc.	ESD	Class I	1997-07-29
K972336	Dermamend Hydrogel Gauze Dressing	Dermarx Corp.	KMF	Class I	1997-07-29
K972272	Laser Peripherals Holmium Bare Fibers	Laser Peripherals LLC	GEX	Class II	1997-07-29
K972266	Gallini Coaxial Introducer	Gallini U.S., LLC	KNW	Class II	1997-07-29
K972253	P3 Universal Phaco Handpiece	Odyssey Technologies, Inc.	HQC	Class II	1997-07-29
K972252	Vista Universal Handpiece	Odyssey Technologies, Inc.	HQC	Class II	1997-07-29
K972195	Powder-Free Nitrile Examination Glove, Blue or White (Non-Colored)	Absolute Synthetic Technologies Malaysia Sdn. Bhd.	LZA	Class I	1997-07-29
K972177	Powdered Nitrile Examination Glove, Blue or White (Non-Colored)	Absolute Synthetic Technologies Malaysia Sdn. Bhd.	LZA	Class I	1997-07-29
K972126	Myringotomy Tube	Mednet Locator, Inc.	ETD	Class II	1997-07-29
K972069	Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips, Rechargeable Battery Pack	Stryker Corp.	FQH	Class II	1997-07-29
K971916	Medical Z, S.a. Medigel Z Scar Management Gel	Medical z, S.A.	MDA	Class I	1997-07-29
K971782	Bone and Marrow Collection System Kit	Biomedical Ent., Inc.	GEY	Class I	1997-07-29
K971764	Welcon Hue-Vu Urinary Drainage Bag	Welcon, Inc.	KNX	Class II	1997-07-29
K971734	Vg 200 Video Gastroscope	Welch Allyn Inc	FDS	Class II	1997-07-29
K971687	Hemodialysis Venous Blood Tubing Set or Similar Trade Name	National Medical Care, Inc.	FJK	Class II	1997-07-29
K971671	Heidelberg Retina Angiograph Fa/icga (Hra/c)	Heidelberg Engineering GmbH	HLI	Class II	1997-07-29
K971597	Comfeel Purilon Gel,15g(3900)/comfeel Purilon Gel,25g(3903)	MEDLINE INDUSTRIES, LP - Northfield	NAE	Class I	1997-07-29
K971571	Rm3 Renal Preservation System--Control Unit	Waters Instruments, Inc.	KDN	Class II	1997-07-29
K971181	The Midview-Medcon's Dicom Viewer	Medcon, Ltd.	IZI	Class II	1997-07-29
K971009	Scar Care	Target Health, Inc.	MDA	Class I	1997-07-29
K970920	Siemens Sc9000/sc9015 Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	DSI	Class II	1997-07-29
K970566	Arglaes Film Dressing	Maersk Medical A/S	FRO	Unclassified	1997-07-29
K970384	Velos Constancy Check Device, Model 55-145	Aktina Medical Physics Corp.	IYE	Class II	1997-07-29
K964886	Ge Logiq 700 Diagnostic Ultrasound System	GE Healthcare	IYN	Class II	1997-07-29
K963195	Wireless EEG Recording System Model W32	Cme Telemetrix, Inc.	GYE	Class II	1997-07-29
K972687	Cardiac Status Controls/troponin I	Spectral Diagnostics, Inc.	JJX	Class I	1997-07-28
K972528	Dyna Glide 2600 Roll-in Ambulance Cot (95759)	Dyna Corp.	FPO	Class II	1997-07-28
K972513	Tinaquant Myoglobin Assay	Boehringer Mannheim Corp.	DDR	Class II	1997-07-28
K972291	Allegiance Non Sterile Powder Free Low Protein Latex Examiation Gloves	Medtronic, Inc.	LYY	Class I	1997-07-28
K972098	Fosfomycin, 200 Mg, Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1997-07-28
K971949	Powder-Free Patient Examination Gloves	Tekmedic (M) Sdn Bhd	LYY	Class I	1997-07-28
K971744	Floor Mask-Ear Loop(bmr-15011)/Floor Mask-Tie(bmr-1503)	Berkley Medical Resources, Inc.	FXX	Class II	1997-07-28
K971695	Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant Warmer	Fisher & Paykel Electronics, Ltd.	FMT	Class II	1997-07-28
K971604	Alexander Manufacturing Co. Rechargeable Battery Part Number Lp5-Fp	Alexander Mfg. Co.	DSH	Class II	1997-07-28
K971318	Mm-1 Movement Monitor	Axon Instruments, Inc.	GYD	Class II	1997-07-28
K964836	Card Guard, Model Cg-7100	Card Guard Scientific Survival, Ltd.	DXH	Class II	1997-07-28
K964425	A-V Impulse System Model 6060	Powell,Goldstein,Frazer & Murphy	JOW	Class II	1997-07-28
K963777	Hyper Pulse Intermittent Topical Oxygen Chamber C-100, Cb-100	Stephenson Industries, Inc.	KPJ	Class II	1997-07-28