Cleared Abbreviated

K031649 - SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES

K031649 is an FDA 510(k) clearance for SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMEN..., manufactured by Fink Engineering Pty, Ltd.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Abbreviated 510(k) pathway after a 191-day FDA review.

K031649 · Fink Engineering Pty, Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K031649

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
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 140d · This submission: 191d
Pathway characteristics
Standards-based clearance path.

CBF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBF Chamber, Hyperbaric

All 67
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K031649.
MILLENIUM, MODELS 2000, 2001 AND 2002
K041007 · Hyperbaric For Life, LLC · Nov 2004
MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
K030418 · Makai Marine Industries, Inc. · Jan 2004
BAY AREA HYPERSCIENCES
K030713 · Bay Area Hypersciences, LLC · Dec 2003
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
K022214 · Mechidyne Systems, Inc. · Feb 2003
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
K021689 · Pan-America Hyperbarics, Inc. · Oct 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
K021690 · Pan-America Hyperbarics, Inc. · Oct 2002
K031649 · SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
Download PDF FDA Summary Fink Engineering Pty,…