Cleared Traditional

K032480 - AUTOSET SPIRIT SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032480 · Resmed, Ltd. · Anesthesiology device
Oct 2003
Decision
65d
Days
Class 2
Risk

K032480 is an FDA 510(k) clearance for the AUTOSET SPIRIT SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Poway, US). The FDA issued a Cleared decision on October 16, 2003 after a review of 65 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.

Submission Details

510(k) Number K032480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2003
Decision Date October 16, 2003
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
160d faster than avg
Panel avg: 225d · This submission: 65d
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 19
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K032480.
Sleepnet Arie Full Face Vented Mask
K251847 · Sleepnet Corporation · Jan 2026
DeltaWave Nasal Pillow System
K253939 · RemSleep Holdings, Inc. · Jan 2026
SleepRes PAP System
K251770 · Sleepres, Inc. · Dec 2025
Personalized Therapy Comfort Settings (PTCS)
K251657 · ResMed Corp · Dec 2025
F&P Nova Nasal Mask
K243583 · Fisher & Paykel Healthcare Limited · Jun 2025
myAir
K250624 · ResMed Corp · May 2025