Cleared Traditional

K984428 - SULLIVAN AUTOSET NASAL CPAP SYSTEM

K984428 is an FDA 510(k) clearance for SULLIVAN AUTOSET NASAL CPAP SYSTEM, manufactured by Resmed, Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K984428 · Resmed, Ltd. · Anesthesiology device
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Jul 1999
Decision
234d
Days
Class 2
Risk

K984428 is an FDA 510(k) clearance for the SULLIVAN AUTOSET NASAL CPAP SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on July 26, 1999 after a review of 234 days - an extended review cycle.

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. 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 - K984428

510(k) Number K984428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1998
Decision Date July 26, 1999
Days to Decision 234 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 140d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

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 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K984428.
OPAP
K991926 · Opap, Inc. · Oct 1999
INFANT FLOW SYSTEM
K991972 · Sensor Medics Corp. · Aug 1999
MONARCH II MINI MASK
K992336 · Respironics, Inc. · Aug 1999
REUSABLE CONTOUR II NASAL MASK
K991648 · Respironics, Inc. · May 1999
NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
K991150 · Nellcor Puritan Bennett France Dvpt. · Apr 1999
INFANT FLOW NCPAP MASKS
K984254 · Sensor Medics Corp. · Feb 1999