Data / Medical devices / United States / Biotricity

Biotricity: FDA-registered device maker in Redwood City, CA, United States, 8 510(k) clearances

Name: Biotricity FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biotricity is registered with the FDA (registration 3014235520) in Redwood City, CA, United States. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 28, 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 one Watch Biotricity

FDA registration number: 3014235520
Address: 203 Redwood Shores Pkwy Suite 600, Redwood City, CA, United States, 94065
Owner or operator: Biotricity (10056742)
Roles: Manufacturer, Repackager or relabeler
First device listed: January 10, 2018
Registered through: 2026
Brand names listed: BIOFLUX Software, Biocore, Biocore Pro, Bioflux, Biokit BP, Biokit O2, Biokit TP

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)	MWJ	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 28, 2022	K222017	Biotres	MWJ	Substantially Equivalent	Biotricity	accessdata.fda.gov
January 19, 2022	K211709	Biotres	MWJ	Substantially Equivalent	Biotricity	accessdata.fda.gov
December 7, 2020	K202173	Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen AOJ Medical Technology Co., Ltd.	accessdata.fda.gov
July 29, 2020	K201040	Bioflux Software II	DSH	Substantially Equivalent	Biotricity	accessdata.fda.gov
December 15, 2017	K172311	BioFlux Device	DXH	Substantially Equivalent	Biotricity, Inc.	accessdata.fda.gov
October 13, 2016	K162571	Bioflux Software	DSH	Substantially Equivalent	Biotricity, Inc.	accessdata.fda.gov
August 21, 2014	K140681	BELTER INFRA-RED EAR THERMOMETER	FLL	Substantially Equivalent	Shenzhen Belter Health Measurement and Analysis TE	accessdata.fda.gov
July 25, 2014	K134029	BELTER BLOOD PRESSURE METER	DXN	Substantially Equivalent	Shenzhen Belter Health Measurement and Analysis TE	accessdata.fda.gov

Compare with other makers

Updated July 28, 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.