Cleared Special

K201551 - KetoSens BT Blood B-Ketone Monitoring System (FDA 510(k) Clearance)

Class I Chemistry device.

K201551 · I-Sens, Inc. · Chemistry device
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Sep 2020
Decision
92d
Days
Class 1
Risk

K201551 is an FDA 510(k) clearance for the KetoSens BT Blood B-Ketone Monitoring System. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on September 9, 2020 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1435 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all I-Sens, Inc. devices

Submission Details

510(k) Number K201551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2020
Decision Date September 09, 2020
Days to Decision 92 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JIN Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1435
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.