Cleared Traditional

K974417 - SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM

K974417 is an FDA 510(k) clearance for SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM, manufactured by ResMed Corp. The device is a Class 2 Anesthesiology device with product code MNS cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K974417 · ResMed Corp · Anesthesiology device
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Jun 1998
Decision
212d
Days
Class 2
Risk

K974417 is an FDA 510(k) clearance for the SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on June 24, 1998 after a review of 212 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 Corp devices

FDA 510(k) Submission Details - K974417

510(k) Number K974417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date June 24, 1998
Days to Decision 212 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 140d · This submission: 212d
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 36
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K974417.
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
K012323 · Respironics, Inc. · Dec 2001
BIPAP SYNCHRONY HC
K992530 · Respironics, Inc. · Mar 2000
BIPAP HARMONY S/T, MODEL 1001445
K984407 · Respironics, Inc. · May 1999
PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM
K942210 · Puritan Bennett Corp. · Feb 1996