Cleared Traditional

K180902 - MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180902 · Medipines Corporation · Anesthesiology device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 225d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
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