Cleared Traditional

K974539 - SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974539 · Resmed, Ltd. · Anesthesiology device
Aug 1998
Decision
246d
Days
Class 2
Risk

K974539 is an FDA 510(k) clearance for the SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM. Classified as Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (product code MNT), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on August 6, 1998 after a review of 246 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.

Submission Details

510(k) Number K974539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1997
Decision Date August 06, 1998
Days to Decision 246 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 225d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
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.