Cleared Traditional

K034053 - TMS SNAPP SOFT NASAL ACCESSORY FOR POSI...

K034053 is an FDA 510(k) clearance for TMS SNAPP SOFT NASAL ACCESSORY FOR POSI..., 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 177-day FDA review.

K034053 · Tiara Medical Systems, Inc. · Anesthesiology device
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Jun 2004
Decision
177d
Days
Class 2
Risk

K034053 is an FDA 510(k) clearance for the TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-30.... 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 June 24, 2004 after a review of 177 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 - K034053

510(k) Number K034053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2003
Decision Date June 24, 2004
Days to Decision 177 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
37d slower than avg
Panel avg: 140d · This submission: 177d
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 K034053.
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K040944 · Resmed, Ltd. · Jun 2004