Cleared Traditional

K240569 - FESL FINK Chamber (FDA 510(k) Clearance)

Also includes:
FEDL FINK Chamber FETL FINK Chamber

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240569 · Fink Engineering Pty, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
266d
Days
Class 2
Risk

K240569 is an FDA 510(k) clearance for the FESL FINK Chamber. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Fink Engineering Pty, Ltd. (Warana, AU). The FDA issued a Cleared decision on November 21, 2024 after a review of 266 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 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 Fink Engineering Pty, Ltd. devices

Submission Details

510(k) Number K240569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2024
Decision Date November 21, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 139d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

Biologics Consulting
Christy Foreman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.