Cleared Traditional

K931884 - SULLIVAN NASAL VPAP SYSTEM

K931884 is the FDA 510(k) clearance for SULLIVAN NASAL VPAP SYSTEM by Rescare , Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 418-day FDA review.

K931884 · Rescare , Ltd. · Anesthesiology device
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Jun 1994
Decision
418d
Days
Class 2
Risk

K931884 is an FDA 510(k) clearance for the SULLIVAN NASAL VPAP SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Rescare , Ltd. (Findley, US). The FDA issued a Cleared decision on June 7, 1994 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Rescare , Ltd. devices

Submission Details

510(k) Number K931884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1993
Decision Date June 07, 1994
Days to Decision 418 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
278d slower than avg
Panel avg: 140d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 212
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K931884.
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
K952292 · Puritan Bennett Corp. · Nov 1995
SPECTRUM(TM) MASK
K936047 · Respironics, Inc. · Mar 1995
PURITAN-BENNETT COMPANION 320 I/E
K934804 · Puritan Bennett Corp. · Feb 1995
NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993
TOTAL FACE MASK
K925920 · Respironics, Inc. · Jul 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590 · Puritan Bennett Corp. · Apr 1993