510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133045Substantially Equivalent

Element Tm Lite Blood Glucose Monitoring System

Infopia Co, Ltd., Anyang, Kyunggi, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133045 is the FDA 510(k) clearance record for ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM, a class II device, cleared for Infopia Co, Ltd. on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 20 510(k) clearances for Infopia Co, Ltd., from to . As of , FDA records show no recalls naming K133045.

Clearance record

Decision date
Received
(195 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
Infopia Co, Ltd. 891 Hogye-Dong, Anyang, Kyunggi, KR
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