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 1259 of 3531

510(k) clearances, page 1259 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060830	Milagro Interference Screw	DePuy Mitek, Inc.	HWC	Class II	2006-06-15
K060817	Omnilink. 018 Biliary Stent System	Abbott Vascular	FGE	Class II	2006-06-15
K060709	Multigent Gentamicin	Seradyn, Inc.	LCD	Class II	2006-06-15
K060524	Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension Cables	Dolphin Medical, Inc.	DQA	Class II	2006-06-15
K060364	Vacu Lab Plain Tube, Vacu Lab Gel & Clot Activator Tube, Vacu Lab Coagulation Tube	Teco Diagnostics	JKA	Class II	2006-06-15
K060237	Cmb Antimicrobial Dressing	Silverleaf Medical Products, Inc.	FRO	Unclassified	2006-06-15
K060192	Apex Knee System	Omni Life Science, Inc.	JWH	Class II	2006-06-15
K053422	Rapidone-Cocaine-150 Test	American Bio Medica Corp.	DIO	Class II	2006-06-15
K053381	Welch Allyn Connex Vital Solutions Software	Welch Allyn Inc	DQA	Class II	2006-06-15
K053037	Acro Biotech Llc Rapid Opiates Urine Test; Catalog# Opi00100	ACRO BIOTECH Inc.	DJG	Class II	2006-06-15
K061475	Astrotilt Manual Wheelchair	Pdg Product Design Group Inc	IOR	Class I	2006-06-14
K061437	Sigma 5000 Series, Imagic	Kontron Medical Systems SAS	IYN	Class II	2006-06-14
K061403	Microlife Wrist Watch Blood Pressure Monitor, Model Bp3ax1-4U	Microlife Intellectual Property GmbH	DXN	Class II	2006-06-14
K061211	Ncb Plating System, Proximal Tibia Plates	Zimmer GmbH	HRS	Class II	2006-06-14
K061080	Ir Pro 250	Lhasa Oms, Inc.	ILY	Class II	2006-06-14
K061007	Good Medy, Disposable Thermometer Sheaths	Good Medy Enterprise, Ltd.	FLL	Class II	2006-06-14
K060875	Abbott Axsym Troponin-I Adv	Abbott Medical	MMI	Class II	2006-06-14
K060814	Dynatron Ion Iontophoresis Electrode	Dynatronics Corp.	EGJ	Class II	2006-06-14
K060705	Carina Home	Draeger, Inc.	CBK	Class II	2006-06-14
K060630	Reflection 3-Hole Shell with Asymmetric Porous Coating	Smith & Nephew, Inc.	LPH	Class II	2006-06-14
K053137	Endotool Drug Dose Calculator	MD Scientific, LLC	NDC	Class II	2006-06-14
K052759	Dan Monopolar Lap Accessories	Dannoritzer Medizintechnik GmbH & Co. KG	GEI	Class II	2006-06-14
K052583	Blue Powder Free Nitrile Examination Gloves	Hartalega Sdn Bhd	LZA	Class I	2006-06-14
K061328	Think Positive Diabetes Management System (T+diabetes System)	E-San Limited	NBW	Class II	2006-06-13
K061296	Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine Calibrator	Diazyme Laboratories, Inc.	LPS	Class II	2006-06-13
K061255	Brainacquirerx / Brainprocessrx Data Suite Version 1.0	Kyron Clinical Imaging, Inc.	LNH	Class II	2006-06-13
K061051	Dose Verification System Patient Dosimetry System, Models Dvs-I-11, Dvs Insertion Tool, Dvs-D-a, Dvs Dosimeter	Sicel Technologies, Inc.	LHN	Class II	2006-06-13
K060311	Epilong Kit for Anesthesiology	Pajunk GmbH Medizintechnologie	CAZ	Class II	2006-06-13
K060280	Ichem 100 Urine Chemistry Analyzer	Iris International, Inc.	JIL	Class II	2006-06-13
K061508	Osom Influenza A&b Test	Genzyme Corporation	PSZ	Class II	2006-06-12
K061454	Exactech Equinoxe Shoulder Stems	Exactech, Inc.	HSD	Class II	2006-06-12
K061341	Palmlight 10, Model 001-00030	Cao Group, Inc.	EBZ	Class II	2006-06-12
K061178	Angiodynamics, Inc. Venacure Procedure Kit	Boston Scientific Corporation	GEX	Class II	2006-06-12
K060716	Versa-Dial Humeral Head Prosthesis	Biomet Manufacturing Corp	MBF	Class II	2006-06-12
K060691	Easy X-Trac System	A. Titan Instruments, Inc.	EMG	Class I	2006-06-12
K060668	Safe Tip Syringe	Devon Safety Products, Inc.	MEG	Class II	2006-06-12
K060249	Ultratine Forehead	Coapt Systems, Inc.	HWC	Class II	2006-06-12
K060248	Ultratine Transbleph	Coapt Systems, Inc.	HWC	Class II	2006-06-12
K060141	Dai-R	Shl Medical, USA	KZH	Class II	2006-06-12
K052934	Dermosonic Non-Invasive Subdermal Therapy System	S.O.R. Internacional, S.A.	IMI	Class II	2006-06-12
K061472	Galileos Implant, V 1.0	Sicat GmbH & Co. KG	LLZ	Class II	2006-06-09
K061173	Cpivision Digital Imaging System	Communications & Power Industries Canada, Inc.	OWB	Class II	2006-06-09
K061160	M-Vu Cad Station	Vucomp, Inc.	LLZ	Class II	2006-06-09
K061088	Sentry OTC Monitor	Honeywell Hommed, LLC	DRG	Class II	2006-06-09
K061087	Genesis OTC Monitor	Honeywell Hommed, LLC	DRG	Class II	2006-06-09
K060914	Trident Anchor	Johnson & Johnson	HWC	Class II	2006-06-09
K060896	Modification to Ontrak Testcup II and Onsite Cupkit	Varian, Inc.	DJC	Class II	2006-06-09
K060871	As101, Blood Pressure Cuff	Wenzhou Longwan Medical Instrument Company	DXQ	Class II	2006-06-09
K060853	Online Tdm Tobramycin	Roche Diagnostics GmbH	KLB	Class II	2006-06-09
K060766	Portable, Electrocardiograph (ECG) Monitor, Model Hcg-801	Omron Healthcare Co., Ltd.	DPS	Class II	2006-06-09