Cleared Traditional

K892434 - KENDALL CURITY OXYGEN MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K892434 · The Kendal Co. · Anesthesiology device
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Aug 1989
Decision
127d
Days
Class 1
Risk

K892434 is an FDA 510(k) clearance for the KENDALL CURITY OXYGEN MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 127 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 The Kendal Co. devices

Submission Details

510(k) Number K892434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date August 15, 1989
Days to Decision 127 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 139d · This submission: 127d
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.