Cleared Traditional

K080527 - TWINGUARD WITH CAPNOGRAPH ACCESSORY

K080527 is an FDA 510(k) clearance for TWINGUARD WITH CAPNOGRAPH ACCESSORY, manufactured by Trawax Pty Limited. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K080527 · Trawax Pty Limited · Anesthesiology device
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Oct 2008
Decision
248d
Days
Class 2
Risk

K080527 is an FDA 510(k) clearance for the TWINGUARD WITH CAPNOGRAPH ACCESSORY. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Trawax Pty Limited (Laguna Niguel, US). The FDA issued a Cleared decision on October 31, 2008 after a review of 248 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Trawax Pty Limited devices

FDA 510(k) Submission Details - K080527

510(k) Number K080527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2008
Decision Date October 31, 2008
Days to Decision 248 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
108d slower than avg
Panel avg: 140d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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