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 1224 of 3531

510(k) clearances, page 1224 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K063224	Gentrisure Human Genomic DNA Reference Control	Gentris Corporation	NZB	Class II	2006-12-22
K063166	I.t.s. Pelvic Reconstruction System	I.T.S. Implantat-Technologie-Systeme GmbH	HRS	Class II	2006-12-22
K063160	Allergeaze Patch Test Chambers	Smartpractice	KXF	Class I	2006-12-22
K063127	Enterococcus Faecalis Pna Fish	Advandx, Inc.	OAH	Class I	2006-12-22
K063119	Lifepak 20 Defibrillator/ Monitor	Physio Control, Inc.	MKJ	Class III	2006-12-22
K063095	Humerus Locking Plating System	Newclip Technics	HRS	Class II	2006-12-22
K063057	Immulite/immulite 1000, Immulite 2000 High Sensitivity Crp	Siemens Healthcare Diagnostics Inc.	NQD	Class II	2006-12-22
K063036	Opus Hc482 Direct Nasal Mask	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2006-12-22
K062965	Chlorinated, Polymer-Coated Powder-Free Latex Examination Glove with Protein Labeling Claim	Kossan Latex Industries (M) Sdn Bhd	LYY	Class I	2006-12-22
K062940	Bone Injection Gun (B.i.g.)	Waismed Ltd.	FMI	Class II	2006-12-22
K062880	Subdermal Wire Electrode, Model Swe	Ives EEG Solutions	GXZ	Class II	2006-12-22
K062879	Traverse Oct Spinal Fixation System	Medtronic Sofamor Danek	MNI	Class II	2006-12-22
K062661	Aequalis Resurfacing Head	TORNIER Inc.	HSD	Class II	2006-12-22
K062533	Bwii EEG Digital, Model Pv 1652; Bwii Psg Digital, Model Pv 1524	Neurovirtual USA, Inc.	OLT	Class II	2006-12-22
K062517	Electrosurgical Hemostatic Forceps Series	Olympus Medical Systems Corp.	KGE	Class II	2006-12-22
K062513	Apex Spine System	Spinecraft LLC	KWP	Class II	2006-12-22
K062314	Horus Laser Keratome	Carl Zeiss Meditec Inc	GEX	Class II	2006-12-22
K062285	Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, Fs Calibrator 1 and Dat Performance Verifiers I, II, III, IV	Ortho-Clinical Diagnostics, Inc.	JXM	Class II	2006-12-22
K062151	Box Peek Vbr System	Innovasis, Inc	MQP	Class II	2006-12-22
K061841	Quanta Lite Intrinsic Factor Elisa	Inova Diagnostics, Inc.	LIG	Class II	2006-12-22
K061615	Interdry Textile with Silver	Milliken Chemical	FRL	Class I	2006-12-22
K061350	Lithodiamond Ultra	Pck Electronic Industry & Trade Co., Ltd.	LNS	Class II	2006-12-22
K060851	Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure Infuser	Smithworks, Inc.	LGZ	Class II	2006-12-22
K060346	Ultrazonix Spine Minimal-Invasive Disc System	Ultrazonix Dnt AB	NTB	Class II	2006-12-22
K063703	Citric Acid 20% Solution, Model 329	Ultradent Products Inc.	KJJ	Unclassified	2006-12-21
K063602	Autopulse Resuscitation System Model100	ZOLL Circulation, Inc.	DRM	Class II	2006-12-21
K063547	Calysto Series IV Physio-Monitoring and Information System	Invivo Corporation	MWI	Class II	2006-12-21
K063518	Hi Vision 900 Diagnostic Ultrasound Scanner	FUJIFILM Healthcare Americas Corporation	IYN	Class II	2006-12-21
K063493	I Review Software(accessory to) Ilab Ultrasound Imaging System) Version1.0	Boston Scientific Corporation	IYN	Class II	2006-12-21
K063492	Vitek 2 Gram Positive Erythromycin for Streptococcus Pneumoniae	bioMerieux, Inc.	LON	Class II	2006-12-21
K063424	Film Digitzer, Model 2908 Mammo Pro	Array Corp.	LMA	Class II	2006-12-21
K063230	Integra Radionics Imagefusion 3	Integra Radionics, Inc.	MUJ	Class II	2006-12-21
K063182	Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-Xxx	Greatbatch Medical	DYB	Class II	2006-12-21
K063055	Vs-800 Vital Signs Monitor	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MWI	Class II	2006-12-21
K062950	Powder Free Sterile Nitrile Surgical Gloves (Blue)	Hartalega Sdn Bhd	KGO	Class I	2006-12-21
K062383	Unisyn Ha Plasma Modular Hip	Hayes Medical, Inc.	LWJ	Class II	2006-12-21
K063750	Xcel 255 Slit Lamp	Reichert, Inc.	HJO	Class II	2006-12-20
K063619	Flipper Detachable Embolization Coils	Cook Inc.	KRD	Class II	2006-12-20
K063616	Trident II Acetabular System	Howmedica Osteonics Corp	LZO	Class II	2006-12-20
K063073	Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems	Candela Corporation	GEX	Class II	2006-12-20
K063072	Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems: 532 and 1064 Nd:yag Handpiece Accessories	Candela Corporation	GEX	Class II	2006-12-20
K063068	Ferrara Blood Glucose Monitoring System, Model 631100	Arkray Factory USA, Inc.	NBW	Class II	2006-12-20
K063015	Ameditech Immutest Multi-Drug Screen Bup/ppx/coc150	Ameditech, Inc.	DJG	Class II	2006-12-20
K062847	Biogel Eclipse Indicator Underglove	Molnlycke Health Care, US LLC	KGO	Class I	2006-12-20
K062841	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic and Susceptibility Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2006-12-20
K062811	Dpilog, Model Dpc-512	Life Outcomes, Inc.	CAF	Class II	2006-12-20
K062626	Cortisol Elisa	Ibl-Hamburg GmbH	CGR	Class II	2006-12-20
K062353	Mozaik Bone Regeneration Matrix - Putty	Integra LifeSciences Corporation	MQV	Class II	2006-12-20
K062277	Atlantis Abutment in Zirconia for Nobel Biocare Replace	Atlantis Components, Inc.	NHA	Class II	2006-12-20
K061461	Mayo Conservative Hip Prosthesis, Model 00.65-8026-010-05	Zimmer GmbH	LPH	Class II	2006-12-20