Cleared Abbreviated

K031649 - SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES (FDA 510(k) Clearance)

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

K031649 · Fink Engineering Pty, Ltd. · Anesthesiology device
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Dec 2003
Decision
191d
Days
Class 2
Risk

K031649 is an FDA 510(k) clearance for the SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Fink Engineering Pty, Ltd. (San Antonio, US). The FDA issued a Cleared decision on December 5, 2003 after a review of 191 days - an extended review cycle.

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: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Fink Engineering Pty, Ltd. devices

Submission Details

510(k) Number K031649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2003
Decision Date December 05, 2003
Days to Decision 191 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
52d slower than avg
Panel avg: 139d · This submission: 191d
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.