Cleared Traditional

S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM (K030797) - FDA 510(k) Clearance

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

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

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

Submission Details

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.

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 119
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K030797.
BIPAP AUTO
K050759 · Respironics, Inc. · Jun 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607 · Respironics, Inc. · Jan 2005
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
K041010 · Respironics, Inc. · May 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004
C2 NASAL MASK
K033759 · Respironics, Inc. · Feb 2004
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
K031460 · Respironics, Inc. · Jun 2003