Data / Medical devices / United States / Telcare, LLC

Telcare, LLC: FDA-registered device maker in Linwood, PA, United States, 1 510(k) clearance

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

Telcare, LLC is registered with the FDA (registration 3008514395) in Linwood, PA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 28, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Telcare, LLC

FDA registration number: 3008514395
Address: 600 West Ridge Road, Suite 200, Linwood, PA, United States, 19061
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 6, 2023
Registered through: 2026
Brand names listed: BioTel Care BGM, BioTel Care Blood Glucose Monitoring System, Philips Ambulatory Virtual Care Blood Glucose Monitoring System, Telcare, Telcare BGM, Telcare Blood Glucose Monitoring System, Telcare Cloud

Devices it lists

Device	Product code	Class	Role	Source
Calculator/Data Processing Module, For Clinical Use	JQP	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Complaint file establishment, Manufacturer, Specification developer	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, 2011	K110571	TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE	NBW	Substantially Equivalent	Telcare, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 30, 2025	96230	Class II	Ongoing	Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009	Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable b	accessdata.fda.gov

Compare with other makers

Updated March 5, 2025. 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.