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 862 of 3530

510(k) clearances, page 862 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122968	Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015	MEDLINE INDUSTRIES, LP - Northfield	OTO	Class II	2012-12-18
K122875	Oricare L2700	Oricare Inc.	FSY	Class II	2012-12-18
K122813	Hemotherm Model 400Ce Cooler/heater System	Gentherm Medical, LLC	DWC	Class II	2012-12-18
K122794	Upsylon Y Mesh	Boston Scientific Corporation	OTO	Class II	2012-12-18
K122734	Aesculap Novosyn Absorbable Suture	Aesculap Inc	GAM	Class II	2012-12-18
K121278	Hermes Medical Imaging Suite V5.2	Hermes Medical Solutions AB	KPS	Class II	2012-12-18
K121105	Nutrisafe 2 Feeding Tube	Vygon Corp.	FPD	Class II	2012-12-18
K113743	Evolution 3E Ventilator	Event Medical Ltd	CBK	Class II	2012-12-18
K122509	Vertiflex Spinous Process Fixation Plate	Vertiflex, Inc.	KWP	Class II	2012-12-17
K122211	Synthes Navigable Pedicle Preparation Instruments	Synthes GmbH	HAW	Class II	2012-12-17
K120955	Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System	Aesculap Inc	JWH	Class II	2012-12-17
K120946	Alpha Cryptococcal Antigen Eia	IMMY, Inc.	MDU	Class II	2012-12-17
K120886	Lacrifast	Hiroyasu Higuchi	OKS	Unclassified	2012-12-17
K110215	Confirm Anti-Estrogen Receptor (Sp1) Rabbit Monoclonal Primary Antibody	Ventana Medical Systems Inc	MYA	Class II	2012-12-17
K123532	Ocelot Pixl Catheter	Avinger, Inc.	PDU	Class II	2012-12-14
K123531	Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular Inc.	DQY	Class II	2012-12-14
K123385	Medilas H Laser Fibers	Dornier Medtech America, Inc.	GEX	Class II	2012-12-14
K123319	Gyrus Acmi Bicoag Hemostasis Probe	Olympus Surgical Technologies America	KNS	Class II	2012-12-14
K123257	Emvera Diolux	Emvera Technologies, LLC	GEX	Class II	2012-12-14
K123203	Maxlock Extreme System Model Mxl	TORNIER Inc.	HRS	Class II	2012-12-14
K123065	Catheter Connections Dualcap Solo	Catheter Connections, Inc.	QBP	Class II	2012-12-14
K123010	On Call Vivid Blood Glucose Monitoring System	Acon Laboratories, Inc.	NBW	Class II	2012-12-14
K122937	Slip-Cath Beacon Tip Catheter Model Scbr (Product Prefix), Shuttle Select Slip-Cath Catheter Model Scbr (Product Prefix)	Cook Inc.	DQO	Class II	2012-12-14
K122840	CT Hdr Tandem/ring Applicator with Rectal Retractor Model 0407	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2012-12-14
K122831	Video System Center	Olympus Medical Systems Corp.	NTN	Class II	2012-12-14
K122827	Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Model Bb811	Medtronic, Inc.	DTZ	Class II	2012-12-14
K122753	Empower Clear	American Orthodontics	NJM	Class II	2012-12-14
K122152	Oxti Inflation Device	Oxti Corporation	MAV	Class II	2012-12-14
K121955	Coughassist T70 Device	Respironics, Inc.	NHJ	Class II	2012-12-14
K121623	BIPAP a 40 Ventilatory Support System	Respironics, Inc.	MNT	Class II	2012-12-14
K121514	Anodyne Anterior Cervical Plate System	Corelink, LLC	KWQ	Class II	2012-12-14
K121498	Percunav	Philips Health Care	JAK	Class II	2012-12-14
K121117	Ndx Abutments	National Dentex Corp	NHA	Class II	2012-12-14
K113779	Conelog Implant System	Altatec GmbH	DZE	Class II	2012-12-14
K113377	Gliadin Iga and Gliadin Lga	Grifols USA, LLC.	MST	Class II	2012-12-14
K113313	Molecular Adsorbent Recirculating(mars)	Gambro Renal Products	FLD	Class II	2012-12-14
K113018	Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform	Beijing Syntech Laser Co., Ltd	GEX	Class II	2012-12-14
K100404	Ascendx Vcf Reduction System	Aoi Medical, Inc.	NDN	Class II	2012-12-14
K123565	Presto 1000 System	Physiosonics, Inc.	IYN	Class II	2012-12-13
K123503	Dc-N3/dc-Ns3 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2012-12-13
K123493	Vex-S 100W Intraoral X-Ray System	Vatech Co., Ltd.	EHD	Class II	2012-12-13
K123492	Ds Anterior, Ds Base, Ds Head-Neck, Ds Head, Flex (S,m,l)	Philips North America LLC	MOS	Class II	2012-12-13
K123448	Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock Adapter with Carmeda Bioactive	Medtronic, Inc.	DTL	Class II	2012-12-13
K123355	Amplivue C. Difficile Assay	Ortho-Clinical Diagnostics, Inc.	OZN	Class II	2012-12-13
K123156	Gore Flow Reversal System Model Gfrs073	W. L. Gore & Associates, Inc.	NTE	Class II	2012-12-13
K123094	Orthodontic Ceramic Brackets	Tomy, Inc.	NJM	Class II	2012-12-13
K122960	Steerable Guiding Sheath, Model Adelante Destino	Oscor Inc.	DYB	Class II	2012-12-13
K122958	Delivery Sheath, Model Adelante Breezeway	Oscor Inc.	DYB	Class II	2012-12-13
K122869	Milagro Interference Screws	DePuy Mitek, Inc.	MAI	Class II	2012-12-13
K122839	Zoll Surepower Single Bay Charger	ZOLL Medical Corporation	MKJ	Class III	2012-12-13