Cleared Traditional

K033841 - RESMED S8 PRIME CPAP SYSTEM

K033841 is the FDA 510(k) clearance for RESMED S8 PRIME CPAP SYSTEM by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K033841 · Resmed, Ltd. · Anesthesiology device
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Mar 2004
Decision
91d
Days
Class 2
Risk

K033841 is an FDA 510(k) clearance for the RESMED S8 PRIME 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 March 10, 2004 after a review of 91 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

Submission Details

510(k) Number K033841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2003
Decision Date March 10, 2004
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 K033841.
OXYGEN DIVERTER VALVE
K033914 · Resmed, Ltd. · Apr 2004
RESMED HOSPITAL NASAL MASK
K040566 · Resmed, Ltd. · Apr 2004
INVACARE POLARIS EX CPAP, MODEL ISP3000
K031064 · Invacare Corp. · Mar 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004
C2 NASAL MASK
K033759 · Respironics, Inc. · Feb 2004
ORACLE ORAL MASK, MODEL HC451A
K033087 · Fisher &Paykel Healthcare , Ltd. · Jan 2004