Cleared Traditional

K970688 - POCKET RESCUE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K970688 · Cheen Houng Ent. Co. , Ltd. · Anesthesiology device
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Sep 1997
Decision
213d
Days
Class 1
Risk

K970688 is an FDA 510(k) clearance for the POCKET RESCUE. Classified as Mask, Oxygen, Non-rebreathing (product code KGB), Class I - General Controls.

Submitted by Cheen Houng Ent. Co. , Ltd. (Taipei (Shulin), TW). The FDA issued a Cleared decision on September 26, 1997 after a review of 213 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5570 - 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 Cheen Houng Ent. Co. , Ltd. devices

Submission Details

510(k) Number K970688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1997
Decision Date September 26, 1997
Days to Decision 213 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
74d slower than avg
Panel avg: 139d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGB Mask, Oxygen, Non-rebreathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5570
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.