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 1701 of 3531

510(k) clearances, page 1701 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K993919	Dynatron 900	Dynatronics Corp.	ITH	Class II	2000-01-03
K993873	Alphatec External Fixation System Compression/distraction Rod	Alphatec Spine, Inc.	KTT	Class II	2000-01-03
K993850	Urinalysis Reagent Strips (10 Parameters)	International Newtech Development, Inc.	JMT	Class I	2000-01-03
K993556	Liquiband Dental	Medlogic Global Limited	EMA	Class II	2000-01-03
K993461	Quest Intersegmental Roller Traction Table	Icon Intl., LLC	JFB	Class II	2000-01-03
K994237	At Home Drug Test, Model 9063	Phamatech Inc.	DKZ	Class II	1999-12-30
K994236	At Home Drug Test, Model 9133	Phamatech Inc.	LCM	Unclassified	1999-12-30
K994234	At Home Drug Test, Model 9083	Phamatech Inc.	DJG	Class II	1999-12-30
K994233	At Home Drug Test, Model 9068	Phamatech Inc.	LAF	Class II	1999-12-30
K994220	At Home Drug Test, Model 9078	Phamatech Inc.	LDJ	Class II	1999-12-30
K994219	At Home Drug Test, Model 9073	Phamatech Inc.	DIO	Class II	1999-12-30
K994186	Disetronic D-Tron Insulin Infusion Pump	Disetronic Medical Systems	LZG	Class II	1999-12-30
K993969	Saljet Single Dose Sterile Saline Topical Solution	Winchester Laboratories, LLC	FRO	Unclassified	1999-12-30
K993330	Thermochem-Ht System	Hemocleanse, Inc.	MLW	Class II	1999-12-30
K993232	Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System	Boston Scientific Corporation	FGE	Class II	1999-12-30
K994197	Disentronic Penfine Injection Pen Needle	Disetronic Medical Systems	FMI	Class II	1999-12-29
K993862	Modus Sagittal Split Plate	Straumann USA, LLC	JEY	Class II	1999-12-29
K993693	Invigra	Indus Medicare, Ltd.	HIS	Class II	1999-12-29
K993621	Health-Plus, Sanitex, Reliance, Blue Pre-Powdered Latex Examination Gloves, with Protein Content Labeling Claim (100 Mic	Pamitex Industries Sdn Bhd	LYY	Class I	1999-12-29
K993575	Resolve Quickanchor	Mitek Products	DZL	Class II	1999-12-29
K993562	Powder Free Latex Sterile Surgical Gloves	TG Medical Sdn Bhd	KGO	Class I	1999-12-29
K993542	Rossmax Automatic Wristwatch Blood Pressure Monitor, Model V46	Rossmax International Ltd.	DXN	Class II	1999-12-29
K993529	Powder Free Latex Examination Gloves, Polymer Coated with Protein Content Labeling Claim (50 Micrograms or Less)	Biografik (Malaysia) Sdn Bhd	LYY	Class I	1999-12-29
K993450	Latex Surgical Gloves, Pre-Powdered	Fitco Dipped Products Pvt., Ltd.	KGO	Class I	1999-12-29
K993338	Integrated Digital Medical Record (Idmr)	Ibm Israel, Ltd.	LLZ	Class II	1999-12-29
K993288	Sulzer Carbomedics Cardiofix Pericardium	Sulzer Carbomedics, Inc.	DXZ	Class II	1999-12-29
K993283	Oscar Net/cd, Model M1.82 600 . O/a/b/c	Arnold & Richter Cine Technik	LLZ	Class II	1999-12-29
K993030	Modification to Isola Spinal System	Depuyacromed	KWQ	Class II	1999-12-29
K992927	Stealthstation Treatment Guidance Platform	Surgical Navigation Technologies, Inc.	HAW	Class II	1999-12-29
K992148	Hydragel-Mini ISO-Ck Kit, Hydragel ISO-Ck Kit, Hydragel 7 Is0-Ck Kit, Hydragel ISO-Ck 15/30 Kit	Morax	CGS	Class II	1999-12-29
K993761	Cardiovascular Measurement System - View	Medis Medical Imaging Systems, B.V.	LLZ	Class II	1999-12-28
K993650	Ureteral Access Sheath Set - New Models	Applied Medical Resources Corp	FED	Class II	1999-12-28
K993643	Nexsystem Ambulatory Patient Monitor Model Nex 100	Nexan Telemed, Ltd.	MWJ	Class II	1999-12-28
K993591	Bladeworks Disposable Alk Tubing	Blade Works, Inc.	KYG	Class I	1999-12-28
K991562	Pascal Medical Ab Meniett 20	Pascal Medical AB	ETY	Class II	1999-12-28
K991541	A-Med Vascular Cannula, Models V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44	A-Med Systems, Inc.	DWF	Class II	1999-12-28
K991441	Cadence Doppler Ultrasound System	Medasonics, Inc.	KNG	Class II	1999-12-28
K994166	Gyrus Endourology System: Axipolar Resectoscope Electrode	Gyrus ACMI, Inc.	KNS	Class II	1999-12-27
K994149	Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.	Bio-Logic Systems Corp.	GWJ	Class II	1999-12-27
K994075	Geiger Disposable Electrosurgical Electrode, Model 435	Geiger Medical Technologies, Inc.	GEI	Class II	1999-12-27
K993993	Hardydisk Amikacin 30Mcg	Hardy Diagnostics	JTN	Class II	1999-12-27
K993936	15Mm Siteselect Breast Biopsy Device, 10 Mm Siteselect Breast Biopsy Device, 5Mm Siteselect Breast Biopsy Device	Imagyn Surgical	KNW	Class II	1999-12-27
K993853	K-Assay Multi-Analyte Calibrator	Kamiya Biomedical Company, LLC	JIX	Class II	1999-12-27
K993851	Sodem Perforator Drive	Sodemsystems	HBB	Class II	1999-12-27
K993771	Careside Direct Bilirubin	Careside, Inc.	CIG	Class II	1999-12-27
K993485	Visualine V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methampe	Sun Biomedical Laboratories, Inc.	DIO	Class II	1999-12-27
K993143	Vitality System	Soma Blue, Inc.	LKY	Class II	1999-12-27
K993142	Elite Custom	Soma Blue, Inc.	LKY	Class II	1999-12-27
K992949	Screeners Marijuana Test, Drugscreen Dip Marijuana Test	Drug Detection Devices, Ltd.	LDJ	Class II	1999-12-27
K992482	Delight II Hair Removal System (the Delight System)	Radiancy, Ltd.	GEX	Class II	1999-12-27