Cleared Traditional

K031935 - TIARA MEDICAL SYSTEMS ADVANTAGE II NASA...

K031935 is an FDA 510(k) clearance for TIARA MEDICAL SYSTEMS ADVANTAGE II NASA..., manufactured by Tiara Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K031935 · Tiara Medical Systems, Inc. · Anesthesiology device
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Mar 2004
Decision
254d
Days
Class 2
Risk

K031935 is an FDA 510(k) clearance for the TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Tiara Medical Systems, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 3, 2004 after a review of 254 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Tiara Medical Systems, Inc. devices

FDA 510(k) Submission Details - K031935

510(k) Number K031935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date March 03, 2004
Days to Decision 254 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
114d slower than avg
Panel avg: 140d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K031935.
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