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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 937 of 3530

510(k) clearances, page 937 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K103434	3B Flex-Lite	3B Products, LLC	BZD	Class II	2011-10-13
K101774	Monarch III IOL Delivery System; Monarch III P Catridge; Monarch III Handpiece (H4)	Alcon Manufacturing, Ltd.	MSS	Class I	2011-10-13
K100163	Nutrisafe 2 Feeding Tubes Model 362.Xxx. 1362.Xxx	Vygon Corp.	FPD	Class II	2011-10-13
K112646	Sonoace R7 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2011-10-12
K112335	Bantam Catheter (280Mm Balloon Lengths)	Clearstream Technologies Ltd.	DQY	Class II	2011-10-12
K112051	Lungpoint Planning and Virtual Bronchoscopic Navigation (Vbn) Software	Broncus Technologies, Inc.	LLZ	Class II	2011-10-12
K112019	Bencox Id Stem, Bencox Metal Head, Bencox Bipolar Cup	Corentec Co., Ltd.	KWY	Class II	2011-10-12
K111543	Virtuoso (Tm) System for Ihc Her2 (4B5)	Ventana Medical Systems Inc	NOT	Class II	2011-10-12
K111264	Cornerstone (R) Psr Cervical Fusion System	Medtronic Sofamor Danek USA Inc	ODP	Class II	2011-10-12
K111200	Mac-Lab System, Cardiolab System, Combolab System, Specialslab System	GE Healthcare	DQK	Class II	2011-10-12
K110993	Femchec Pressure Managemet Device	Femasys Inc.	LKF	Class II	2011-10-12
K110646	Beammed Sunlight Miniomni Bone Sonometer	Beam-Med, Ltd.	MUA	Class II	2011-10-12
K110153	Sfc Vertebral Body Replacement	Konigsee Implantate GmbH	MQP	Class II	2011-10-12
K103115	Prodigy Diabetes Management Software	Prodigy Diabetes Care, LLC	NBW	Class II	2011-10-12
K112652	Suresigns Vs2+ -Suresigns Vsi	Philips North America LLC	DXN	Class II	2011-10-11
K112629	Onset Access Catheter System	Onset Medical Corporation	DQY	Class II	2011-10-11
K112615	Aequalis Ascend Modular Reverse Shoulder System	TORNIER Inc.	PHX	Class II	2011-10-11
K112254	Apex Kirschner Wires and Steinmann Pins	Apex Tools & Orthopedics Co.	HTY	Class II	2011-10-11
K112017	Raumedic Icp Monitoring System	Raumedic AG	GWM	Class II	2011-10-11
K111994	Smith & Nephew Cannulated Screws and Washers	Smith & Nephew, Inc.	HWC	Class II	2011-10-11
K111875	Relieva Spin Sinus Dilation System	Acclarent Inc	LRC	Class I	2011-10-11
K110694	Concorde Bullet Spinal System	Johnson & Johnson	MAX	Class II	2011-10-11
K102063	Health-E-Connect System	Alr Technologies	NBW	Class II	2011-10-11
K112772	Ortholoc(tm) Bone Screws	Wrightmedicaltechnologyinc	HWC	Class II	2011-10-07
K112756	Fortify(tm) and Fortify(tm)-R Corpectomy Spacers	Globus Medical, Inc.	MQP	Class II	2011-10-07
K112635	U by Kotex Sleek Unscented Menstrual Tampons	Kimberly-Clark Corporation	HEB	Class II	2011-10-07
K112460	Multiple	Larson Medical Products, Inc.	IYE	Class II	2011-10-07
K112446	Tomotherapy Treatment System	Accuray Incorporated	MUJ	Class II	2011-10-07
K112263	Monopolar Curved Scissors Tip Cover Accessory	Intuitive Surgical, Inc.	NAY	Class II	2011-10-07
K112115	Mectacer Biolox(r) Delta Femoral Heads	Medacta International SA	LZO	Class II	2011-10-07
K111859	Iceedge 2.4 Cryoablation Needle,iceedge 2.4 Cryoablation Needle Multipack	Galil Medical Ltd.	GEH	Class II	2011-10-07
K111784	Venus Swan System	Venus Concept Inc.	GEI	Class II	2011-10-07
K111640	Precision Flow(r) - Heliox	Vapotherm Inc.	BTT	Class II	2011-10-07
K111532	Montblanc Surgical Contra-Angle and Straight Handpiece	Anthogyr SAS	EGS	Class I	2011-10-07
K111419	Osteomed Hand Fusion System	Osteomed	HRS	Class II	2011-10-07
K111404	Huibao Body Fat Scale	Zhongshan Huibao Weighing Apparatus Co., Ltd.	MNW	Class II	2011-10-07
K111320	Globalcardio	Cardiocomm Solutions, Inc.	DSH	Class II	2011-10-07
K110836	Cls Brevius Stem with Kinectiv Technology	Zimmer GmbH	KWA	Class III	2011-10-07
K110780	Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech Clinical Systmes Elitrol I & II	ELITechGroup Inc	CIG	Class II	2011-10-07
K110687	Relieva Stratus Pro Microflow Spacer (Frontal)	Acclarent Inc	KAM	Class I	2011-10-07
K110471	Babi Plus Infant Nasal Cannula System	A Plus Medical	BZD	Class II	2011-10-07
K102772	Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid Calibrator (Mpat Cal)	Siemens Heatlhcare Diagnostics, Inc.	OAV	Class II	2011-10-07
K102316	Glucose Shepherd Blood Glucose Monitoring System	Broadmaster Biotech Corporation	CGA	Class II	2011-10-07
K112579	Wildcat 5F Guidewire Support Catheter	Avinger, Inc.	DQY	Class II	2011-10-06
K112571	Xl Extraction Catheter	Vascular Solutions LLC	QEZ	Class II	2011-10-06
K112037	Range Spinal System (Mesa and Denali)	K2M, Inc	MNI	Class II	2011-10-06
K111647	C2 Nervemonitor System with Accessories	Inomed Medizintechnik GmbH	GWF	Class II	2011-10-06
K111566	Dryview Chroma Imaging System	Eastman Kodak Company	LMC	Class II	2011-10-06
K111371	On Call Chosen Blood Glucose Monitoring System	Acon Laboratories, Inc.	CGA	Class II	2011-10-06
K111343	Crosstex Isofluid Plus Surgical Earloop Mask-Blue, Crosstex Isofluid Plus Fogfree Surgical Earloop Face Mask-Blue, Cross	Crosstex International, Inc.	FXX	Class II	2011-10-06