Cleared Traditional

K252078 - BreathePal Bilevel (GFM50-MD2201)

K252078 is an FDA 510(k) clearance for BreathePal Bilevel (GFM50-MD2201), manufactured by Compal Electronics, Inc.. The device is a Class 2 Anesthesiology device with product code MNS cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K252078 · Compal Electronics, Inc. · Anesthesiology device
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Mar 2026
Decision
258d
Days
Class 2
Risk

K252078 is an FDA 510(k) clearance for the BreathePal Bilevel (GFM50-MD2201). Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Compal Electronics, Inc. (Taipei City, TW). The FDA issued a Cleared decision on March 17, 2026 after a review of 258 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Compal Electronics, Inc. devices

FDA 510(k) Submission Details - K252078

510(k) Number K252078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2025
Decision Date March 17, 2026
Days to Decision 258 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
118d slower than avg
Panel avg: 140d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNS Device Classification - Class 2, Special Controls

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - MNS Ventilator, Continuous, Non-life-supporting

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