Cleared Traditional

K180902 - MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

K180902 is an FDA 510(k) clearance for MediPines Gas Exchange Monitor (GEM), manufactured by Medipines Corporation. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K180902 · Medipines Corporation · Anesthesiology device
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Jan 2019
Decision
280d
Days
Class 2
Risk

K180902 is an FDA 510(k) clearance for the MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Medipines Corporation (Anaheim Hill, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 280 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 Medipines Corporation devices

FDA 510(k) Submission Details - K180902

510(k) Number K180902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2018
Decision Date January 11, 2019
Days to Decision 280 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
140d slower than avg
Panel avg: 140d · This submission: 280d
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 230
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