510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170463Substantially Equivalent

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

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

K170463 is the FDA 510(k) clearance record for KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System, a class I device, cleared for I-Sens, Inc. on under FDA product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)). FDA records list 27 510(k) clearances for I-Sens, Inc., from to . As of , FDA records show no recalls naming K170463.

Clearance record

Decision date
Received
(422 days to decision)
Product code
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation
21 CFR 862.1435
Device class
Class I
Review panel
Clinical Chemistry
Applicant
I-Sens, Inc. 43, Banpo-Daero 28-Gil, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIN

Trailing 12 months

FDA records hold no clearances under product code JIN in the trailing twelve months.

FDA records show no clearances under product code JIN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260