Cleared Traditional

K042727 - POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A

K042727 is an FDA 510(k) clearance for POCKET SIZE RESUSCITATOR/MODEL: M16201R..., manufactured by Foremount Ent. Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K042727 · Foremount Ent. Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K042727

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 140d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBP Valve, Non-rebreathing

All 86
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