Cleared Traditional

K970516 - SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM

K970516 is the FDA 510(k) clearance for SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K970516 · Resmed, Ltd. · Anesthesiology device
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May 1997
Decision
87d
Days
Class 2
Risk

K970516 is an FDA 510(k) clearance for the SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Sydney, New South Wales, AU). The FDA issued a Cleared decision on May 9, 1997 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Resmed, Ltd. devices

Submission Details

510(k) Number K970516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1997
Decision Date May 09, 1997
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 246
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K970516.
GOODKNIGHT 418 CPAP SYSTEM
K980365 · Nellcor Puritan Bennett, Inc. · Jul 1998
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
K970771 · Resmed, Ltd. · Jun 1997
MORPHEE PLUS ALPHA
K964019 · Nellcor Puritan Bennett, Inc. · Jun 1997
QUARTET CLINICAL SYSTEM
K963761 · Respironics, Inc. · Apr 1997
BIPAP DUET SYSTEM
K964363 · Respironics, Inc. · Jan 1997
WHISPER SWIVEL II EXHALATION PORT
K962203 · Respironics, Inc. · Dec 1996