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 2026-11-02, 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 1022 of 3531

510(k) clearances, page 1022 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100953	Microlife Non-Contact Infrared Forehead Thermometer, Model Fr1dz1	Microlife Intellectual Property GmbH	FLL	Class II	2010-05-17
K100240	Orthopediatrics Pediloc Tibia Plate System	Orthopediatrics Corp	HRS	Class II	2010-05-17
K100220	Polaris Spinal System	Ebi, LLC	NKB	Class II	2010-05-17
K100203	Handheld Pulse Oximeter Model Md300a/ Md300k2/ Md300m	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2010-05-17
K100788	Cocr Rods	Globus Medical, Inc.	NKB	Class II	2010-05-14
K100704	Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion Device	Disetronic Medical Systems	FRN	Class II	2010-05-14
K100521	Comfysleeve 1-75 and Lymphapod Sleeves, for Use with Lp Optimal and Plus	MEGO AFEK AC Ltd.	JOW	Class II	2010-05-14
K100294	Synthetic Powder-Free Vinyl Patient Examination Gloves	Zibo Yinghao Medical Products Co., Ltd.	LYZ	Class I	2010-05-14
K100271	Vari Ax Distal Radius Line Extensions of Xxl Plates	Howmedica Osteonics Corp	HRS	Class II	2010-05-14
K100047	Surefit Dual Dispersive Electrode	ConMed Corporation	GEI	Class II	2010-05-14
K100010	Hdl Cholesterol (Hdlx) Assay	Siemens Healthcare Diagnostics Inc.	LBS	Class I	2010-05-14
K094054	Modifcation to: Nuvasive Neurovision EMG Endotracheal Tube	NuVasive Inc	GWF	Class II	2010-05-14
K094046	Lncs Oximetry Sensors, Reprocessed Lncs Oximetry Sensors	Masimo Corporation	DQA	Class II	2010-05-14
K093794	Smart-Read Eztest-Steam Scbi and Test Pack	Sgm Biotech, Inc.	FRC	Class II	2010-05-14
K093738	MRI Patient Positioning Devices	Medtec LLC	LNH	Class II	2010-05-14
K092602	FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System	Abbott Medical	NBW	Class II	2010-05-14
K101056	Variax Elbow System	Howmedica Osteonics Corp	HRS	Class II	2010-05-13
K100897	Legion Porous + Ha Tibial Baseplates	Smith & Nephew, Inc.	MBH	Class II	2010-05-13
K100697	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shijiazhuang Universal Channel Plastic Co., Ltd.	LYZ	Class I	2010-05-13
K100433	Immulite 2000 Cmv Igm, Immulite Cmv Igm Controls, and Immulite 200 Cmv Igm Adjustor Model L2kcm2, L2kcm6, Lcmc1, Lcmc2,	Siemens Healthcare Diagnostics Inc.	LKQ	Class II	2010-05-13
K100353	Spinewand Surgical Device	ArthroCare Corporation	GEI	Class II	2010-05-13
K100265	Diamond Anterior Cervical Plate System	Spinal Elements, Inc	KWQ	Class II	2010-05-13
K100089	Synthes T-Pal Spacer	Synthes GmbH	MAX	Class II	2010-05-13
K093716	Babi Plus Infant Nasal Cannula System	A Plus Medical	BZD	Class II	2010-05-13
K093123	Biomerix Ventral Hernia Repair Mesh, Model Sm3-Tab	Biomerix Corporation	FTL	Class II	2010-05-13
K092164	Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9Ua	Shenzhen Delicate Electronics Co., Ltd.	OQQ	Class II	2010-05-13
K090633	Lensar Laser System	LENSAR, Inc	OOE	Class II	2010-05-13
K101215	Nuance	Discus Dental LLC	EBF	Class II	2010-05-12
K101062	Glider Pta Balloon Catheter	Trireme Medical, Inc.	LIT	Class II	2010-05-12
K100560	Easy Talk Blood Glucose Monitoring System Model: 6277	Biotest Medical Corp.	NBW	Class II	2010-05-12
K100537	Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model Fcs9, Twblue, Gablue	Stryker Sustainability Solutions	NLQ	Unclassified	2010-05-12
K100503	Pulpdent Copal Varnish with Fluoride	Pulpdent Corporation	LBH	Class II	2010-05-12
K100336	Multicode - Rtx Herpes Simplex Virus 1 and 2 Kit, Model 3711	Eragen Biosciences	OQO	Class II	2010-05-12
K100235	Filtek Supreme Ultra Flowable Restorative	3M Company	EBF	Class II	2010-05-12
K094012	Capnostream20 with Micromedico2 Module	Oridion Capnography, Inc.	CCK	Class II	2010-05-12
K093905	Trilogy 202 Ventilator	Respironics, Inc.	CBK	Class II	2010-05-12
K093710	The Moses Appliance	Allen J. Moses, Dds, Ltd.	LRK	Class II	2010-05-12
K093590	Planmeca Promax 3D Max	Planmeca Oy	MUH	Class II	2010-05-12
K093114	Thermo Scientific Dri Amphetamines Assay	Microgenics Corporation	DKZ	Class II	2010-05-12
K093087	Bwf-5 Medical Laser Series	LiteCure, LLC	GEX	Class II	2010-05-12
K092789	Virtuosaph Plus Endoscopic Vessel Harvesting System	Terumo Cardiovascular Systems Corporation	GCJ	Class II	2010-05-12
K092586	Male Latex Condom (Straight Side or Contoured or Flared in Shape, Either Textured or Non-Textured , Lubricated or Non-Lu	Innolatex (Thailand) Limited	HIS	Class II	2010-05-12
K092219	Navigator Clinical Guidence System	Applied Physiology Pty, Ltd.	DXG	Class II	2010-05-12
K092116	Easycell Cell Locator	Medica Corp.	JOY	Class II	2010-05-12
K091255	Minxray, Model: Bpd60	Minxray Inc	EHD	Class II	2010-05-12
K101264	Tempus Ic Professional Patient Monitor	Remote Diagnostic Technologies Ltd.	MWI	Class II	2010-05-11
K100839	Barirep	Gorbec Pharmaceutical Services, Inc.	FRO	Unclassified	2010-05-11
K100691	Omni V Sbrt Positioning System, Model Rt-4500	Bionix Development Corp.	IYE	Class II	2010-05-11
K100406	Fora V20 Blood Glucose Monitoring System	Taidoc Technology Corporation	CGA	Class II	2010-05-11
K100238	Hfn 125 Degree 9-13 Mm, 180Mm, Hfn 130 Degree 9-13 Mm, Hfn Rh 125 Degree 9-13Mm	Depuy Orthopaedics Inc.	HSB	Class II	2010-05-11