Cleared Traditional

K080243 - PORTABLE OXYGEN UNIT SCA900 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K080243 · San Cheong Co. , Ltd. · Anesthesiology device
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Apr 2009
Decision
432d
Days
Class 1
Risk

K080243 is an FDA 510(k) clearance for the PORTABLE OXYGEN UNIT SCA900. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by San Cheong Co. , Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 7, 2009 after a review of 432 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all San Cheong Co. , Ltd. devices

Submission Details

510(k) Number K080243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2008
Decision Date April 07, 2009
Days to Decision 432 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 139d · This submission: 432d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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.