Cleared Traditional

K953039 - VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K953039 · Dadsun Corp., Ltd. · Anesthesiology device
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Sep 1995
Decision
94d
Days
Class 1
Risk

K953039 is an FDA 510(k) clearance for the VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Dadsun Corp., Ltd. (Taipei, TW). The FDA issued a Cleared decision on September 15, 1995 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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 Dadsun Corp., Ltd. devices

Submission Details

510(k) Number K953039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1995
Decision Date September 15, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 139d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
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.