Cleared Traditional

K905148 - TEMPERATURE PROBE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K905148 · Tec II Medical, Inc. · Anesthesiology device
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Apr 1991
Decision
137d
Days
Class 1
Risk

K905148 is an FDA 510(k) clearance for the TEMPERATURE PROBE. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Tec II Medical, Inc. (Blue Springs, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tec II Medical, Inc. devices

Submission Details

510(k) Number K905148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date April 01, 1991
Days to Decision 137 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 139d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.