Cleared Traditional

K823141 - OXYGEN MASKS

K823141 is an FDA 510(k) clearance for OXYGEN MASKS, manufactured by Seven Harvest Intl. Import & Export. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823141 · Seven Harvest Intl. Import & Export · Anesthesiology device
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Nov 1982
Decision
35d
Days
Class 1
Risk

K823141 is an FDA 510(k) clearance for the OXYGEN MASKS. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Seven Harvest Intl. Import & Export (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982 after a review of 35 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 Seven Harvest Intl. Import & Export devices

FDA 510(k) Submission Details - K823141

510(k) Number K823141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date November 29, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
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 25
Devices cleared under the same product code (BYG) and FDA review panel - the closest regulatory comparables to K823141.
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
STOCK #64091-PEDIATRIC OXYGEN MASK
K823532 · B & F Medical Products, Inc. · Jan 1983
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