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 1480 of 3531

510(k) clearances, page 1480 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023974	Aloe Vera & Vitamin E Powderfree Latex Examination Gloves	Top Glove Sdn. Bhd.	LYY	Class I	2003-02-13
K023072	Powder Free Nitrile Examination Gloves, Purple Color	Arista Latindo Industrial, Ltd. P.T.	LZA	Class I	2003-02-13
K023012	Smartset Hv Bone Cement	Depuy Orthopaedics Inc.	LOD	Class II	2003-02-13
K022865	6203	Contemporary Products, Inc.	NFB	Class II	2003-02-13
K022815	Multiple Patient Examination Gloves Powdered Latex	Pt. Smartglove Indonesia	LYY	Class I	2003-02-13
K021588	Electro Neuromuscular Stimulator, Model Bmls02-5	BioMedical Life Systems Inc.	IPF	Class II	2003-02-13
K030338	Iclear Phototherapy System, Model Fgcm0002	Curelight, Ltd.	GEX	Class II	2003-02-12
K030116	Enhance-S Plus H	Conception Technology, Inc.	MQL	Class II	2003-02-12
K030106	Stealthstation System Advanced Contour Registration Software Module	Medtronic Navigation, Inc	HAW	Class II	2003-02-12
K024164	Comfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a, Pemufocon a) Rigid Gas Permeable (Rgp) Daily Wear Contact	Metro Optics, Inc.	HQD	Class II	2003-02-12
K024147	Paxscan 4030 Medical Digital Imaging System	Varian Medical Systems, Inc.	MQB	Class II	2003-02-12
K024116	Wiener Lab. Bilirubina Direct Aa	Wiener Laboratories Saic	CIG	Class II	2003-02-12
K024082	Hemosil Factor VII Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2003-02-12
K024005	Welch Allyn Vital Sign Monitor with Mp506	Welch Allyn Inc	DXN	Class II	2003-02-12
K023992	Wiener Lab Colinesterasa Aa	Wiener Laboratories Saic	DIH	Class I	2003-02-12
K023825	Film Processor, Model Life Ray Pro 2500	S.A.I.E.P. S.r.l.	IXW	Class II	2003-02-12
K023801	Film Processor, Model Life Ray Pro 1000	S.A.I.E.P. S.r.l.	IXW	Class II	2003-02-12
K023707	A16 Blood Flow Measurement System	D. E. Hokanson, Inc.	JOM	Class II	2003-02-12
K022532	Tissuelink Bipolar Floating Ball Device	Medtronic Navigation, Inc	GEI	Class II	2003-02-12
K021962	Olympus Ultrasonic Surgical System	Olympus Optical Co., Ltd.	LFL	Unclassified	2003-02-12
K021580	Optilock Implantable Access Port, Models #1700-01, 1700-02, 1700-03, 1700-04 and 1700-05	LeMaitre Vascular Inc.	LJT	Class II	2003-02-12
K021469	Minolta Pulsox-2	Konica Minolta Sensing, Inc.	DQA	Class II	2003-02-12
K021193	Fortune Silicone Vacuum Suction, Model #1300	Fortune Medical Instrument Corp.	HDB	Class II	2003-02-12
K021138	Sleepscreen/apnoescreen Cardio	Erich Jaeger, Inc.	MNR	Class II	2003-02-12
K030313	Siemens Infinity Sc 6002Xl Modifications	Siemens Medical Solutions USA, Inc.	MHX	Class II	2003-02-11
K030199	Ge Mobile Discovery St Pet CT Imaging System	General Electric Co.	KPS	Class II	2003-02-11
K030065	Wako Nefa Linearity Set	FUJIFILM Healthcare Americas Corporation	JJX	Class I	2003-02-11
K023944	Bayer Diagnostics Clinitest Pregnancy Test	Bayer Corp.	JHI	Class II	2003-02-11
K023925	Mark I Thermal Imager	Ix-Dr, Inc.	LHQ	Class I	2003-02-11
K023915	Sterile Powdered Latex Patient Examination Gloves	Sanrea Healthcare Private Limited	LYY	Class I	2003-02-11
K023912	Powder Free Latex Surgeon's Gloves Contains 50 Megm or Less of Total Water Extractable per Gram	Sanrea Healthcare Private Limited	KGO	Class I	2003-02-11
K023910	Sterile Patient Powderfree Latex Examination Gloves	Sanrea Healthcare Private Limited	LYY	Class I	2003-02-11
K023842	Clearfil Se Bond Plus	Kuraray Medical, Inc.	KLE	Class II	2003-02-11
K023805	Laerdal Paediatric Pocket Mask, Model 820050	Laerdal Medical a/S	CBP	Class II	2003-02-11
K023793	1St Response Intermediate Manual Resuscitator	Abbott Medical	BTM	Class II	2003-02-11
K023419	Trilaminate Drapes/tiburon	Medtronic, Inc.	KKX	Class II	2003-02-11
K023401	Eg-3830Ut, Video Ultrasound Gastroscope	Pentax Precision Instrument Corp.	ODG	Class II	2003-02-11
K023255	Technos Mp, Model Au6	Esaote North America, Inc	IYN	Class II	2003-02-11
K023248	Lifestent Lp Sds Biliary Endoprosthesis	Orbusneich Medical, Inc.	FGE	Class II	2003-02-11
K022747	Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-Up Pedi System	Hydropure Systems, Inc.	FIP	Class II	2003-02-11
K022642	Twlight, Model Isp 9600	Invacare GmbH	BZD	Class II	2003-02-11
K021852	Olympus Psd-20 Electrosurgical System & Its Associated Accessories	Olympus Optical Co., Ltd.	GEI	Class II	2003-02-11
K020534	Medstar System, Models 533-300	Cybernet Medical	DXH	Class II	2003-02-11
K030257	Nobel Perfect Implant System	Nobel Biocare Uas, Inc.	DZE	Class II	2003-02-10
K030226	Thor Ddii 830Cl3 Laser System	Thor Intl.	NHN	Class II	2003-02-10
K024153	Bd Phoenix Automated Microbiology System - Tetracycline - 0.5-16 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-02-10
K024128	Allon 2001 Version 5	Mtre Advanced Technology, Ltd.	DWJ	Class II	2003-02-10
K024064	Polaris Ds	Syneron Medical, Ltd.	GEX	Class II	2003-02-10
K023800	Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017	Aircast, Inc.	JOW	Class II	2003-02-10
K023785	Lung Nodule Assessment and Comparison Option	Philips North America LLC	JAK	Class II	2003-02-10