Cleared Traditional

K852623 - OXY-ONE

K852623 is an FDA 510(k) clearance for OXY-ONE, manufactured by Ashai Co. , Ltd.. The device is a Class 1 Anesthesiology device with product code BYG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K852623 · Ashai Co. , Ltd. · Anesthesiology device
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Sep 1985
Decision
90d
Days
Class 1
Risk

K852623 is an FDA 510(k) clearance for the OXY-ONE. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on September 18, 1985 after a review of 90 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 Ashai Co. , Ltd. devices

FDA 510(k) Submission Details - K852623

510(k) Number K852623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date September 18, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K852623.
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
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