510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061328Substantially Equivalent

Think Positive Diabetes Management System (T+diabetes System)

E-San Limited, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061328 is the FDA 510(k) clearance record for THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM), a class II device, cleared for E-San Limited on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 2 510(k) clearances for E-San Limited, from to . As of , FDA records show no recalls naming K061328.

Clearance record

Decision date
Received
(32 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
E-San Limited 2001 Pennsylvania Ave. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBW

Trailing 12 months
3 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 20261