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 910 of 3530

510(k) clearances, page 910 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112392	Hivox Biotek Inc.	Hivox Biotek Inc.	NUH	Class II	2012-03-19
K112268	Codan Safefeed Enteral Feeding Reservoir	Codan US Corp.	KNT	Class II	2012-03-19
K112078	Endocem Mta (Mineral Trioxide Aggregate)	Maruchi	KIF	Class II	2012-03-19
K110536	Powder-Free Vinyl Patient Examination Gloves	Zibo Tengyue Plastic Products Co., Ltd.	LYZ	Class I	2012-03-19
K120485	Nihon Kohden Qp-160 Ak Trend Program with the Addition of Dsa Asymmetry Trend and Fft P	Nihon Kohden America Inc	OMA	Class II	2012-03-16
K120480	Gore(r) Embolic Filter	W. L. Gore & Associates, Inc.	NTE	Class II	2012-03-16
K120373	Insorb Absorbalbe Staple	Incisive Surgical, Inc.	GDW	Class II	2012-03-16
K120188	Electrocardiograph	Edan Instruments, Inc.	DPS	Class II	2012-03-16
K120060	E-Cube 9	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2012-03-16
K120031	Chesapeake Spinal System	K2M, Inc	OVD	Class II	2012-03-16
K113811	V2.6 Software for the Labsystem Pro Ep Recording System	C.R. Bard Inc., Bard Electrophysiology Division	DQK	Class II	2012-03-16
K113788	Deflex Acrilato	Nuxen S.r.l.	EBI	Class II	2012-03-16
K113766	Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter Transfer Guide Tube Set Varisource Luer Tran	Varian Medical Systems, Inc.	JAQ	Class II	2012-03-16
K113763	Srm-Stitch 8F Srm-Stitch 8F with Guidewire	Nobles Medical Technologies II, Inc.	GAW	Class II	2012-03-16
K113558	BD BACTEC Plus Aerobic/F Culture Vials (plastic)	Becton Dickinson & Co	MDB	Class I	2012-03-16
K113515	Horizon Cardiology ECG Management	Change Healthcare Israel Ltd.	DQK	Class II	2012-03-16
K113474	1.5T Gem Flex Coil	NeoCoil, LLC	MOS	Class II	2012-03-16
K113420	Rnaretain	Asuragen, Inc.	OZF	Class II	2012-03-16
K113320	Novation Element Femoral Stem, 12/14 Collarless Standard/high Offset Ha Coated Press-Fit, Sz 8-12	Exactech, Inc.	MEH	Class II	2012-03-16
K113239	Full Automatic (Nibp) Blood Pressure Monitor (Model Hl168kf)	Health & Life Corporation	DXN	Class II	2012-03-16
K112718	Nuvasive Nvm5 System	NuVasive Inc	ETN	Class II	2012-03-16
K112154	Femto Ldv	Sie Ag,Surgical Instument Engineering	HQF	Class II	2012-03-16
K111541	Endo-Express (R) Handpiece	Essential Dental Systems, Inc.	EGS	Class I	2012-03-16
K110337	Universal Maxillary Molar	Oco Biomedical	DZE	Class II	2012-03-16
K120677	Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)	Trireme Medical, Inc.	LIT	Class II	2012-03-15
K120660	Conquest 40 Pta Dilatation Catheter	Bard Peripheral Vascular Inc	LIT	Class II	2012-03-15
K120608	Endoscopic Applicator	Micromedics, Inc.	GCJ	Class II	2012-03-15
K120120	Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue La1 Delivery Sheath Amplatzer Torqvue La2 Selivery Sheath	Abbott Medical	DQY	Class II	2012-03-15
K113791	B-Genin, R-Genin	Berkeley Advanced Biomaterials	MQV	Class II	2012-03-15
K113777	Quidel Molecular Influenza A+b	Ortho-Clinical Diagnostics, Inc.	OZE	Class II	2012-03-15
K113749	Disposable Powder Free Vinyl Synthetic Exam Gloves, with Aloe Vera, Green Color	Full Synergy Medical Products, Inc.	LYZ	Class I	2012-03-15
K113712	Im-11 Pneumatic Microinjector	Narishige Co., Ltd.	MQJ	Class II	2012-03-15
K113387	Citieffe Titanium Nailing System	Citieffe Inc.	HSB	Class II	2012-03-15
K113090	Leveen Superslim Needle Electrode	Boston Scientific Corporation	GEI	Class II	2012-03-15
K112998	Autopulse Resuscitation System Model 1000	ZOLL Circulation, Inc.	DRM	Class II	2012-03-15
K112404	Concentric Balloon Guide Catheter	Concentric Medical, Inc.	DQY	Class II	2012-03-15
K112052	Carefusion Nicolet Edx	Medtronic, Inc.	GWF	Class II	2012-03-15
K111933	Covidien Nellcor Respiration Rate Software Application, Version 1.0	Medtronic, Inc.	BZQ	Class II	2012-03-15
K120439	Bioplex 2200 Ebv Igg and Syphilis Igg	Bio-Rad Laboratories Inc.	LIP	Class II	2012-03-14
K120115	Orthosize	Orthosize, LLC	LLZ	Class II	2012-03-14
K120074	Foundation Spinal System	The Skeletal Design Partnership, Ltd.	NKB	Class II	2012-03-14
K113756	Highly Cross Linked Ve Central Peg Patella Highly Cross Linked Ve Tri-Peg Patella Highly Cross Linked Ve Metal Backed Pa	Encore Medical, LP	OIY	Class II	2012-03-14
K113700	Viavalve Safety IV Catheter	Abbott Medical	FOZ	Class II	2012-03-14
K112969	Air-Bag System	Niigata Mechatronics Co., Ltd.	LHN	Class II	2012-03-14
K112902	Enflow IV Fluid Warmer	Vital Signs, Inc.	LGZ	Class II	2012-03-14
K111820	Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage	BM Korea Co., Ltd.	ODP	Class II	2012-03-14
K102189	Powder Free Nitrle Examination Gloves with Chemotherapy Labeling Claim	Latexx Manufacturing Sdn.Bhd.	LZC	Class I	2012-03-14
K113688	Megabeam Reusable Fiber Optic Delivery System	Biolitec Medical Devices, Inc.	GEX	Class II	2012-03-13
K113354	Veta Peritoneal Dialysis Catheter	PFM Medical GmbH	FJS	Class II	2012-03-13
K113157	Aileron Interspinous Fixation System	Life Spine	MNI	Class II	2012-03-13