510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170614Substantially Equivalent

CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System

I-SENS, Inc., Seoul, KR / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170614 is the FDA 510(k) clearance record for CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System, a class II device, cleared for I-Sens, Inc. on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 27 510(k) clearances for I-Sens, Inc., from to . As of , FDA records show no recalls naming K170614.

Clearance record

Decision date
Received
(232 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
I-Sens, Inc. 43, Banpo-Daero 82-Gil, Seocho-Gu, Seoul, 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