Cleared Special

K012207 - ADVANTAGE NASAL MASK

K012207 is an FDA 510(k) clearance for ADVANTAGE NASAL MASK, manufactured by Tiara Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 7-day FDA review.

K012207 · Tiara Medical Systems, Inc. · Anesthesiology device
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Jul 2001
Decision
7d
Days
Class 2
Risk

K012207 is an FDA 510(k) clearance for the ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, .... 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 July 23, 2001 after a review of 7 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K012207

510(k) Number K012207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date July 23, 2001
Days to Decision 7 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 140d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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 K012207.
REMSTAR AUTO CPAP SYSTEM
K012554 · Respironics, Inc. · Jan 2002
MINIME NASAL MASK, MODEL P/N 50220
K013306 · Sleepnet Corporation · Nov 2001
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
K012034 · Sensor Medics Corp. · Jul 2001
BIPAP PRO BI-LEVEL SYSTEM
K011714 · Respironics, Inc. · Jun 2001
ORACLE ORAL MASK
K003894 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
REMREST
K002763 · Medical Industries America, Inc. · May 2001