Cleared Special

TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 (K051583) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051583 · Tiara Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
142d
Days
Class 2
Risk

K051583 is an FDA 510(k) clearance for the TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TM.... 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 November 4, 2005 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tiara Medical Systems, Inc. devices

Submission Details

510(k) Number K051583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2005
Decision Date November 04, 2005
Days to Decision 142 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 140d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

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 K051583.
INVACARE'S TWILIGHT II NASAL MASKS
K061874 · Invacare Corp. · Sep 2006
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
K061034 · Respironics, Inc. · Jun 2006
COMFORTLITE NASAL MASK
K053352 · Respironics, Inc. · Feb 2006
M-SERIES PRO CPAP SYTEM
K052110 · Respironics, Inc. · Oct 2005
BIPAP AUTO
K050759 · Respironics, Inc. · Jun 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607 · Respironics, Inc. · Jan 2005