Cleared Traditional

K171028 - CARESCAPE Respiratory MOdules

K171028 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 134-day FDA review.

K171028 · GE Healthcare Finland Oy · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 2017
Decision
134d
Days
Class 2
Risk

K171028 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 August 17, 2017 after a review of 134 days - within the typical 510(k) review window.

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 - K171028

510(k) Number K171028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2017
Decision Date August 17, 2017
Days to Decision 134 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
6d faster than avg
Panel avg: 140d · This submission: 134d
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 K171028.
Panoramic Oxygen Mask (POM)
K172365 · Pom Medical, LLC · Apr 2018
OmniCap
K171235 · Respirion, Inc. · Jan 2018
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K172904 · Philips Medizin Systeme Boeblingen GmbH · Dec 2017
Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
K151421 · Salter Labs · Mar 2016
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
K150245 · GE Healthcare Finland Oy · Jul 2015
SOFTECH Plus ETCO2 Cannula
K143469 · Teleflexmedical, Inc. · Feb 2015