Cleared Traditional

K823532 - STOCK #64091-PEDIATRIC OXYGEN MASK

K823532 is an FDA 510(k) clearance for STOCK #64091-PEDIATRIC OXYGEN MASK, manufactured by B & F Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K823532 · B & F Medical Products, Inc. · Anesthesiology device
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Jan 1983
Decision
37d
Days
Class 1
Risk

K823532 is an FDA 510(k) clearance for the STOCK #64091-PEDIATRIC OXYGEN MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by B & F Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B & F Medical Products, Inc. devices

FDA 510(k) Submission Details - K823532

510(k) Number K823532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1982
Decision Date January 05, 1983
Days to Decision 37 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
103d faster than avg
Panel avg: 140d · This submission: 37d
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 22
Devices cleared under the same product code (BYG) and FDA review panel - the closest regulatory comparables to K823532.
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
TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC
K860871 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
PEDIATRIC OXYGEN MASKS
K811711 · Airlife, Inc. · Jul 1981
PEDIATRIC OXYGEN OR AEROSOL MASKS,
K802323 · Airlife, Inc. · Oct 1980
PEEP FACE MASK
K801883 · Vital Signs, Inc. · Sep 1980