Cleared Traditional

K930656 - SULLIVAN III NASAL CPAP SYSTEM

K930656 is the FDA 510(k) clearance for SULLIVAN III NASAL CPAP SYSTEM by Rescare , Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K930656 · Rescare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
399d
Days
Class 2
Risk

K930656 is an FDA 510(k) clearance for the SULLIVAN III NASAL CPAP 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 March 15, 1994 after a review of 399 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Rescare , Ltd. devices

Submission Details

510(k) Number K930656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1993
Decision Date March 15, 1994
Days to Decision 399 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
259d slower than avg
Panel avg: 140d · This submission: 399d
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 K930656.
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