Cleared Traditional

K033276 - VPAP III ST-A

K033276 is an FDA 510(k) clearance for VPAP III ST-A, 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 241-day FDA review.

K033276 · Resmed, Ltd. · Anesthesiology device
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Jun 2004
Decision
241d
Days
Class 2
Risk

K033276 is an FDA 510(k) clearance for the VPAP III ST-A. 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 June 7, 2004 after a review of 241 days - an extended review 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: 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 Resmed, Ltd. devices

FDA 510(k) Submission Details - K033276

510(k) Number K033276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2003
Decision Date June 07, 2004
Days to Decision 241 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
101d slower than avg
Panel avg: 140d · This submission: 241d
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 K033276.
BIPAP SYNCHRONY
K063533 · Respironics, Inc. · Feb 2007
VPAP III ST-A/KIDSTA MASK SYSTEM
K060105 · Resmed, Ltd. · Apr 2006
VPAP ADAPT
K051364 · Resmed, Ltd. · Aug 2005
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
K031656 · Respironics, Inc. · Jul 2003
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
K020777 · Respironics, Inc. · Mar 2002
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
K012323 · Respironics, Inc. · Dec 2001