Cleared Traditional

K041209 - RESMED S8 PIONEER CPAP SYSTEM

K041209 is the FDA 510(k) clearance for RESMED S8 PIONEER CPAP SYSTEM by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K041209 · Resmed, Ltd. · Anesthesiology device
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Jul 2004
Decision
52d
Days
Class 2
Risk

K041209 is an FDA 510(k) clearance for the RESMED S8 PIONEER CPAP 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 July 1, 2004 after a review of 52 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 K041209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date July 01, 2004
Days to Decision 52 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 140d · This submission: 52d
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 K041209.
MIRAGE SWIFT
K042403 · Resmed, Ltd. · Oct 2004
HC604 CPAP HUMIDIFIER
K041900 · Fisher &Paykel Healthcare , Ltd. · Aug 2004
RESMED HOSPITAL FULL FACE MASK
K041362 · Resmed, Ltd. · Jul 2004
IMASK TM
K041309 · Vital Signs, Inc. · Jun 2004
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
K040941 · Fisher &Paykel Healthcare , Ltd. · Jun 2004
RESCONTROL II
K040944 · Resmed, Ltd. · Jun 2004