Cleared Traditional

K123195 - CARESCAPE RESPIRATORY MODULES

K123195 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 CCL cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K123195 · GE Healthcare Finland Oy · Anesthesiology device
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Feb 2013
Decision
140d
Days
Class 2
Risk

K123195 is an FDA 510(k) clearance for the CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on February 28, 2013 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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 - K123195

510(k) Number K123195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2012
Decision Date February 28, 2013
Days to Decision 140 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
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 42
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K123195.
Percent Oxygen Sensors
K213933 · Careox, LLC · Aug 2022
OxyMinder
K213948 · Bio-Med Devices, Inc. · Mar 2022
Accu O2 Oxygen Analyzer
K173807 · Precision Medical, Inc. · May 2018
PRECISION OXYGEN MONITOR
K063096 · Precision Medical, Inc. · Feb 2007
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
K051092 · Ge Healthcare · May 2005
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999