Cleared Traditional

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON (K911801) - FDA 510(k) Clearance

Class I Chemistry device.

K911801 · Gds Technology, LLC · Chemistry device
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Jul 1991
Decision
69d
Days
Class 1
Risk

K911801 is an FDA 510(k) clearance for the KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on July 1, 1991 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1435 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gds Technology, LLC devices

Submission Details

510(k) Number K911801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1991
Decision Date July 01, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

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.

Regulatory Peers - JIN Nitroprusside, Ketones (urinary, Non-quant.)

All 23
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K911801.
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KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
K170463 · I-Sens, Inc. · Apr 2018
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