Cleared Traditional

DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (K946046) - FDA 510(k) Clearance

Class I General Hospital device.

K946046 · Deroyal Critical Care, Div. Deroyal Technologies · General Hospital
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Jul 1995
Decision
219d
Days
Class 1
Risk

K946046 is an FDA 510(k) clearance for the DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP. Classified as Thermometer, Clinical Color Change (product code FQZ), Class I - General Controls.

Submitted by Deroyal Critical Care, Div. Deroyal Technologies (Powell, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 219 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2900 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Deroyal Critical Care, Div. Deroyal Technologies devices

Submission Details

510(k) Number K946046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date July 19, 1995
Days to Decision 219 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 129d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQZ Thermometer, Clinical Color Change
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2900
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.