Cleared Traditional

ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE (K946005) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946005 · Astral, Ltd. · General Hospital
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Sep 1995
Decision
290d
Days
Class 2
Risk

K946005 is an FDA 510(k) clearance for the ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Astral, Ltd. (Millersville, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 290 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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 Astral, Ltd. devices

Submission Details

510(k) Number K946005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date September 25, 1995
Days to Decision 290 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
161d slower than avg
Panel avg: 129d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMT Warmer, Infant Radiant

All 7
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K946005.
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