Cleared Traditional

K042727 - POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A (FDA 510(k) Clearance)

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

K042727 · Foremount Ent. Co., Ltd. · Anesthesiology device
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Mar 2005
Decision
168d
Days
Class 2
Risk

K042727 is an FDA 510(k) clearance for the POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Foremount Ent. Co., Ltd. (Ta Ya Hsiang, Taichung, TW). The FDA issued a Cleared decision on March 18, 2005 after a review of 168 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 Foremount Ent. Co., Ltd. devices

Submission Details

510(k) Number K042727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2004
Decision Date March 18, 2005
Days to Decision 168 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 139d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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.