Cleared Traditional

K954402 - ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

K954402 is an FDA 510(k) clearance for ET-TUBE PLACEMENT DETECTOR (WITH COLIBR..., manufactured by Icor AB. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K954402

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
Combination Product No
PCCP Authorized No
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.

CCK Device Classification - Class 2, Special Controls

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

All 192
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