Cleared Traditional

K060105 - VPAP III ST-A/KIDSTA MASK SYSTEM

K060105 is an FDA 510(k) clearance for VPAP III ST-A/KIDSTA MASK SYSTEM, manufactured by Resmed, Ltd.. The device is a Class 2 Anesthesiology device with product code MNS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K060105 · Resmed, Ltd. · Anesthesiology device
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Apr 2006
Decision
84d
Days
Class 2
Risk

K060105 is an FDA 510(k) clearance for the VPAP III ST-A/KIDSTA MASK SYSTEM. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Resmed, Ltd. (Poway, US). The FDA issued a Cleared decision on April 7, 2006 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Resmed, Ltd. devices

FDA 510(k) Submission Details - K060105

510(k) Number K060105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2006
Decision Date April 07, 2006
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNS Device Classification - Class 2, Special Controls

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - MNS Ventilator, Continuous, Non-life-supporting

All 42
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K060105.
BIPAP SYNCHRONY WITH AVAPS
K070328 · Respironics Inc., Sleep & Home Respiratory Group · May 2007
BIPAP AUTOSV
K063540 · Respironics, Inc. · Feb 2007
BIPAP SYNCHRONY
K063533 · Respironics, Inc. · Feb 2007
VPAP ADAPT
K051364 · Resmed, Ltd. · Aug 2005
VPAP III ST-A
K033276 · Resmed, Ltd. · Jun 2004
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
K031656 · Respironics, Inc. · Jul 2003