Cleared Traditional

K892434 - KENDALL CURITY OXYGEN MASK

K892434 is an FDA 510(k) clearance for KENDALL CURITY OXYGEN MASK, manufactured by The Kendal Co.. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 127-day FDA review.

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

FDA 510(k) Submission Details - K892434

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 140d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

BYG Device Classification - Class 1, General Controls

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.

Regulatory Peers - BYG Mask, Oxygen

All 17
Devices cleared under the same product code (BYG) and FDA review panel - the closest regulatory comparables to K892434.
SEAL RING FOR NASAL CPAP
K921499 · Devilbiss Health Care, Inc. · Sep 1992
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K912633 · Salter Labs · Jul 1991
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
K890193 · Puritan Bennett Corp. · Mar 1989
SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE
K865047 · Salter Labs · Feb 1987
MEDIUM CONCENTRATION OXYGEN MASKS
K860869 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
AEROSOL MASKS/ADULT & PAEDIATRIC
K860870 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986