Cleared Traditional

K150245 - CARESCAPE Respiratory Modules

K150245 is an FDA 510(k) clearance for CARESCAPE Respiratory Modules, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K150245 · GE Healthcare Finland Oy · Anesthesiology device
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Jul 2015
Decision
165d
Days
Class 2
Risk

K150245 is an FDA 510(k) clearance for the CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-s.... Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on July 17, 2015 after a review of 165 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 GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K150245

510(k) Number K150245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date July 17, 2015
Days to Decision 165 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 140d · This submission: 165d
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 152
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K150245.
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