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 2026-10-26, 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 753 of 3530

510(k) clearances, page 753 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131173	FIA Blood Glucose Monitoring System (G2)	HMD Biomedical, Inc.	NBW	Class II	2014-09-18
K130312	Iroot Fm	Innovative BioCeramix, Inc	KIF	Class II	2014-09-18
K142336	GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System	ARKRAY Factory, Inc.	CGA	Class II	2014-09-17
K142300	Arrow GPSCath Balloon Dialation Catheter (150 cm)	Hotspur Technologies	LIT	Class II	2014-09-17
K142179	D-Kat Z-Ype	Keeler Ltd.	HKY	Class II	2014-09-17
K142048	Emprint Procedure Planning Application	Medtronic, Inc.	LLZ	Class II	2014-09-17
K141638	Propper Insight Binocular Indirect Ophthalmosope	Propper Manufacturing Co., Inc.	HLI	Class II	2014-09-17
K141481	Trc-Nw400 Non-Mydriatic Retinal Camera	Topcon Corp.	HKI	Class II	2014-09-17
K141450	Axiom 2.8	Anthogyr SAS	DZE	Class II	2014-09-17
K141260	Electronic Pulse Stimulator	Shenzhen Jingkehui Electronic Co.., Ltd.	NUH	Class II	2014-09-17
K141069	Lung Density Analysis	Imbio, Inc.	JAK	Class II	2014-09-17
K140416	Trekker, Trekker Transit	Convaid Products LLC	IOR	Class I	2014-09-17
K134035	Transonic Hcm 103 System	Transonic Systems Inc	DXG	Class II	2014-09-17
K123329	Da Vinvi Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2014-09-17
K142309	GEM Flow COUPLER Device and System	Synovis Life Technologies, Inc.	MVR	Class II	2014-09-16
K141405	Mobis II St Spinal Implant	Signus Medizintechnik GmbH	MAX	Class II	2014-09-16
K141108	Yusheng	Zibo Yusheng Plastic Products Co., Ltd.	LYZ	Class I	2014-09-16
K140496	Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents	Siemens Healthcare Diagnostics Inc.	CDD	Class II	2014-09-16
K140377	Xtag Gastrointestinal Pathogen Panel (Gpp)/xtag Data Analysis Software for Gpp (Tdas Gpp)	Luminex Molecular Diagnostics Inc	PCH	Class II	2014-09-16
K140017	Transonic Hcm 102 System	Transonic Systems Inc	DXG	Class II	2014-09-16
K142306	Flower Upper Extremity Plating Set	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HRS	Class II	2014-09-15
K142295	Sirius Femoral Stem, Size 30A	Zimmer GmbH	JDI	Class II	2014-09-15
K141321	Glucostabilizer Insulin Dosing Calculator	Medical Decision Network	NDC	Class II	2014-09-15
K141137	Stereos Workstation	EOS imaging	LLZ	Class II	2014-09-15
K141122	Harmonic Scallop Blade, Generator G11	Ethicon Endo-Surgery Inc	GEI	Class II	2014-09-15
K141018	Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit, Oral-B Test Drive Refill Kit	Procter & Gamble Co.	JEQ	Class I	2014-09-15
K140928	Abpm7100	I.E.M. GmbH	DXN	Class II	2014-09-15
K140912	Somatom Scope/somatom Scope Power	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-09-15
K140758	M-Pm-Disc (Pink)	Merz Dental GmbH	EBI	Class II	2014-09-15
K140362	Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes, Katalyst Revolver Illuminated Probes	Katalyst Surgical, LLC	HQF	Class II	2014-09-15
K140039	Polycryl	Aurolab	GAM	Class II	2014-09-15
K142241	LARIAT sulture Delivery Device	Sentreheart, Inc.	GAT	Class II	2014-09-12
K142226	Pilot Ultra Diode Laser	Cao Group, Inc.	GEX	Class II	2014-09-12
K142225	Pilot Elite Diode Laser	Cao Group, Inc.	GEX	Class II	2014-09-12
K142223	Pilot Pro Diode Laser	Cao Group, Inc.	GEX	Class II	2014-09-12
K142134	C-Wire Double Ended Orthopedic Wires	Conmed Corporation, Largo	HTY	Class II	2014-09-12
K142077	Mylabgamma	Esaote S.p.A.	IYN	Class II	2014-09-12
K142008	Mylabseven, Mylabalpha	Esaote S.p.A.	IYN	Class II	2014-09-12
K141971	Biograph True Pet/ct Family Software	Siemens Medical Solutions USA, Inc.	KPS	Class II	2014-09-12
K141949	Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping, Titanium	AAP Implantate AG	HWC	Class II	2014-09-12
K141602	Dx-D Imaging Package	AGFA Healthcare Corp.	MQB	Class II	2014-09-12
K141439	Orthodontic Acrylic (Not Finalized)	Bisco Inc	EBI	Class II	2014-09-12
K141419	Zvplasty	Zavation	NDN	Class II	2014-09-12
K141384	Whisperject Autoinjector	Scandinavian Health Ltd.	KZH	Class II	2014-09-12
K141235	Profemur Renaissance Classic Long Neck Hip Stems	Microport Orthopedics Inc.	LZO	Class II	2014-09-12
K141033	Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy Ag Antimicrobial Wound Contact Negativ	Argentum Medical, LLC	OMP	Class II	2014-09-12
K141025	Artimes Balloon Dilatation Catheter	BrosMed Medical Co.,Ltd.	LOX	Class II	2014-09-12
K140608	Merit Heparin-Coated Inqwire Diagnostic Guidewire	Merit Medical Systems, Inc.	DQX	Class II	2014-09-12
K140367	Architect Px Extracellular Collagen Matrix	Harbor MedTech, Inc.	KGN	Unclassified	2014-09-12
K140050	Nitrile Powder Free Examination Glove with Colloidal Oatmeal Usp Skin Protectant Drug - Dkbu /Dark Blue	Hartalega Sdn Bhd	LZA	Class I	2014-09-12