Cleared Traditional

K980721 - SULLIVAN AUTOSET

K980721 is the FDA 510(k) clearance for SULLIVAN AUTOSET by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K980721 · Resmed, Ltd. · Anesthesiology device
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Sep 1998
Decision
189d
Days
Class 2
Risk

K980721 is an FDA 510(k) clearance for the SULLIVAN AUTOSET. 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 September 1, 1998 after a review of 189 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

Submission Details

510(k) Number K980721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1998
Decision Date September 01, 1998
Days to Decision 189 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
49d slower than avg
Panel avg: 140d · This submission: 189d
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 K980721.
REUSABLE CONTOUR II NASAL MASK
K991648 · Respironics, Inc. · May 1999
INVACARE CPAP
K982242 · Invacare Corp. · Jan 1999
SULLIVAN MIRAGE FULL FACE MASK
K982530 · Resmed, Ltd. · Oct 1998
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