Skip to the page
Get started – free

Data / Medical devices / United States / BiometerPlus USA, Inc.

BiometerPlus USA, Inc.: FDA-registered device maker in Fremont, CA, United States, 11 510(k) clearances

BiometerPlus USA, Inc. is registered with the FDA (registration 3010830834) in Fremont, CA, United States. It lists 22 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 30, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch BiometerPlus USA, Inc.
FDA registration number
3010830834
FEI number
3004525092
Address
48531 Warm Springs Blvd., #416, Fremont, CA, United States, 94539
Owner or operator
BiometerPlus USA, Inc. (10046647)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
April 21, 2014
Registered through
2026
Brand names listed
BIO Aseptic Irrigation Syringe, BIO Dental Floss, BIO Dental Radiographic Film, BIO Neck Fixation Brace, BIO Peak Flow Meter, BIO TAPE and BANDAGE, BIO Toothbrush, BIO Vaginal Speculum and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Ferric Ion-Sulfuric, CholesterolCHD1Manufactureraccessdata.fda.gov
Calibrator, PrimaryJIS2Repackager or relabeler, Specification developeraccessdata.fda.gov
Electrophoresis, Cholesterol Via Esterase-Oxidase, HdlLBT1Manufactureraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Manufactureraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeler, Specification developeraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Manufactureraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Repackager or relabeler, Specification developeraccessdata.fda.gov
Meter, Peak Flow, SpirometryBZH2Repackager or relabeler, Specification developeraccessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use OnlyQRL2Repackager or relabeler, Specification developeraccessdata.fda.gov
Nadp Reduction, 6-Phosphogluconate DehydrogenaseJND1Manufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Specification developeraccessdata.fda.gov
Orthosis, Cervical-Thoracic, RigidIQF1Repackager or relabeler, Specification developeraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeler, Specification developeraccessdata.fda.gov
Set, Administration, IntravascularFPA2Specification developeraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufactureraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Repackager or relabeler, Specification developeraccessdata.fda.gov
Syringe, AntistickMEG2Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Specification developeraccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeler, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 30, 2022K221970Lancing deviceQRLSubstantially EquivalentSteriLance Medical (Suzhou), Inc.accessdata.fda.gov
May 26, 2021K203196Peak flow meterBZHSubstantially EquivalentShanghai Sonmol Medical Equipment Co., Ltd.accessdata.fda.gov
September 11, 2020K191639TK Insulin Syringe with/without Saftey Retractable DeviceMEGSubstantially EquivalentAnhui Tiankang Medical Technology Co., Ltd.accessdata.fda.gov
August 26, 2020K191640TK Intravascular Administration SetFPASubstantially EquivalentAnhui Tiankang Medical Technology Co., Ltd.accessdata.fda.gov
August 6, 2020K191644TK Safety NeedleFMISubstantially EquivalentAnhui Tiankang Medical Technology Co., Ltd.accessdata.fda.gov
January 6, 2020K191642TK Sterile Piston Syringe without NeedleFMFSubstantially EquivalentAnhui Tiankang Medical Technology Co., Ltd.accessdata.fda.gov
October 12, 2017K171782Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugsLZASubstantially EquivalentBlue Sail Medical Co.,Ltdaccessdata.fda.gov
May 12, 2014K131531TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLEMEGSubstantially EquivalentAnhui Tiankang Medical Products Co., Ltd.accessdata.fda.gov
August 9, 2005K050182Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEMCGASubstantially EquivalentBiomedix, Inc.accessdata.fda.gov
July 11, 2005K050887GONGDONG DISPOSABLE VAGINAL SPECULUMHIBSubstantially EquivalentZhejiang Gongdong Medical Plastic Factoryaccessdata.fda.gov
May 21, 2004K033627Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEMCGASubstantially EquivalentBiomedix, Inc.accessdata.fda.gov

Compare with other makers

Updated August 30, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.