Cleared Traditional

K030797 - S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM

Also marketed or referenced as:
AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM

K030797 is an FDA 510(k) clearance for S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM, manufactured by ResMed Corp. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K030797 · ResMed Corp · Anesthesiology device
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Mar 2004
Decision
363d
Days
Class 2
Risk

K030797 is an FDA 510(k) clearance for the S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by ResMed Corp (Poway, US). The FDA issued a Cleared decision on March 10, 2004 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Corp devices

FDA 510(k) Submission Details - K030797

510(k) Number K030797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2003
Decision Date March 10, 2004
Days to Decision 363 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 140d · This submission: 363d
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 286
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K030797.
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
RESMED S8 PRIME CPAP SYSTEM
K033841 · Resmed, Ltd. · Mar 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004
C2 NASAL MASK
K033759 · Respironics, Inc. · Feb 2004