Cleared Traditional

K952325 - ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

K952325 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 74-day FDA review.

K952325 · Icor AB · Anesthesiology device
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Jul 1995
Decision
74d
Days
Class 2
Risk

K952325 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 July 31, 1995 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icor AB devices

FDA 510(k) Submission Details - K952325

510(k) Number K952325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date July 31, 1995
Days to Decision 74 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
66d faster than avg
Panel avg: 140d · This submission: 74d
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
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K952325.
ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)
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