Cleared Traditional

K242798 - Airmod (FDA 510(k) Clearance)

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

K242798 · Heroic Faith International , Ltd. · Anesthesiology device
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Feb 2025
Decision
165d
Days
Class 2
Risk

K242798 is an FDA 510(k) clearance for the Airmod. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Heroic Faith International , Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 28, 2025 after a review of 165 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 Heroic Faith International , Ltd. devices

Submission Details

510(k) Number K242798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2024
Decision Date February 28, 2025
Days to Decision 165 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
26d slower than avg
Panel avg: 139d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Consultant

RQM+
Pierre Bounaud

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 173
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