Cleared Traditional

DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST (K091919) - FDA 510(k) Clearance

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

K091919 · Sunrise Medical · Anesthesiology device
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Sep 2009
Decision
90d
Days
Class 2
Risk

K091919 is an FDA 510(k) clearance for the DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sunrise Medical (Somerset, US). The FDA issued a Cleared decision on September 28, 2009 after a review of 90 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.

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Submission Details

510(k) Number K091919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date September 28, 2009
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K091919.
PERFORMAX TOTAL FACE MASK
K103395 · Respironics, Inc. · Mar 2011
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K110008 · Respironics, Inc. · Feb 2011
GOLIFE NASAL MASK
K102502 · Respironics, Inc. · Dec 2010
RESPIRONICS SLEEPEASY CPAP SYSTEM
K091112 · Respironics, Inc. · May 2009
COMFORTLITE NASAL MASK
K082558 · Respironics, Inc. · Mar 2009
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
K072996 · Respironics, Inc. · Dec 2007