Cleared Traditional

K952805 - TEMPERATURE PROBE-TP550

K952805 is an FDA 510(k) clearance for TEMPERATURE PROBE-TP550, manufactured by Contour Medical Technology, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K952805 · Contour Medical Technology, Inc. · General Hospital
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Apr 1996
Decision
290d
Days
Class 2
Risk

K952805 is an FDA 510(k) clearance for the TEMPERATURE PROBE-TP550. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Contour Medical Technology, Inc. (Lavergne, US). The FDA issued a Cleared decision on April 4, 1996 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.

FDA 510(k) Submission Details - K952805

510(k) Number K952805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1995
Decision Date April 04, 1996
Days to Decision 290 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

FMT Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K952805.
TEMPERATURE PROBE-TP250
K952801 · Contour Medical Technology, Inc. · Apr 1996
TEMPERATURE PROBE-TP350
K952803 · Contour Medical Technology, Inc. · Apr 1996
TEMPERATURE PROBE-TP450
K952804 · Contour Medical Technology, Inc. · Apr 1996
TEMPERATURE PROBE-TP650
K952807 · Contour Medical Technology, Inc. · Apr 1996
DRAGER INFANT RADIANT WARMERN RH600
K953489 · Drager, Inc. · Feb 1996
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
K946005 · Astral, Ltd. · Sep 1995
K952805 · TEMPERATURE PROBE-TP550
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