Cleared Traditional

TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 (K031935) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 131
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K031935.
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
K041010 · Respironics, Inc. · May 2004
INVACARE POLARIS EX CPAP, MODEL ISP3000
K031064 · Invacare Corp. · Mar 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004
C2 NASAL MASK
K033759 · Respironics, Inc. · Feb 2004
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
K031460 · Respironics, Inc. · Jun 2003
TWLIGHT, MODEL ISP 9600
K022642 · Invacare Corp. · Feb 2003