Cleared Abbreviated

K001121 - OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K001121 · Engineered Medical Technology, Inc. · Anesthesiology device
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Nov 2001
Decision
601d
Days
Class 2
Risk

K001121 is an FDA 510(k) clearance for the OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS). Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Engineered Medical Technology, Inc. (Victoria, US). The FDA issued a Cleared decision on November 29, 2001 after a review of 601 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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 Engineered Medical Technology, Inc. devices

Submission Details

510(k) Number K001121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2000
Decision Date November 29, 2001
Days to Decision 601 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
462d slower than avg
Panel avg: 139d · This submission: 601d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.