Cleared Traditional

K970771 - SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM

K970771 is an FDA 510(k) clearance for SULLIVAN AUTOSET PORTABLE II NASAL CPAP..., 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 109-day FDA review.

K970771 · Resmed, Ltd. · Anesthesiology device
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Jun 1997
Decision
109d
Days
Class 2
Risk

K970771 is an FDA 510(k) clearance for the SULLIVAN AUTOSET PORTABLE II 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 June 20, 1997 after a review of 109 days - within the typical 510(k) review window.

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 - K970771

510(k) Number K970771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date June 20, 1997
Days to Decision 109 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
31d faster than avg
Panel avg: 140d · This submission: 109d
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 K970771.
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K964019 · Nellcor Puritan Bennett, Inc. · Jun 1997
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
K970516 · Resmed, Ltd. · May 1997
QUARTET CLINICAL SYSTEM
K963761 · Respironics, Inc. · Apr 1997