510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K110571Substantially Equivalent

Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use

Telcare, LLC, Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110571 is the FDA 510(k) clearance record for TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE, a class II device, cleared for Telcare, Inc. on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list one 510(k) clearance for Telcare, Inc. As of , FDA records show one recall naming K110571.

Clearance record

Decision date
Received
(149 days to decision)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Telcare, Inc. 3 Bethesda Metro Center, Bethesda MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBW

Trailing 12 months
2 clearances under product code NBW in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260