Cleared Traditional

K954402 - ET-TUBE PLACEMENT DETECTOR (WITH COLIBR...

K954402 is the FDA 510(k) clearance for ET-TUBE PLACEMENT DETECTOR (WITH COLIBR... by Icor AB. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K954402 · Icor AB · Anesthesiology device
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May 1996
Decision
245d
Days
Class 2
Risk

K954402 is an FDA 510(k) clearance for the ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR). Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on May 22, 1996 after a review of 245 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Icor AB devices

Submission Details

510(k) Number K954402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1995
Decision Date May 22, 1996
Days to Decision 245 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 140d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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