Cleared Traditional

K093070 - DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST

K093070 is an FDA 510(k) clearance for DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, manufactured by Sunrise Medical. The device is a Class 2 Anesthesiology device with product code MNS cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K093070 · Sunrise Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
118d
Days
Class 2
Risk

K093070 is an FDA 510(k) clearance for the DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Sunrise Medical (Somerset, US). The FDA issued a Cleared decision on January 26, 2010 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Sunrise Medical devices

FDA 510(k) Submission Details - K093070

510(k) Number K093070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date January 26, 2010
Days to Decision 118 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
22d faster than avg
Panel avg: 140d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNS Device Classification - Class 2, Special Controls

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - MNS Ventilator, Continuous, Non-life-supporting

All 40
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K093070.
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K102465 · Respironics, Inc. · Mar 2011
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
K101130 · Respironics, Inc. · Sep 2010
VPAP III ST-A
K093731 · Resmed, Ltd. · Mar 2010
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K092818 · Respironics, Inc. · Jan 2010
VPAP TX
K092186 · Resmed, Ltd. · Dec 2009
BIPAP AUTOSV ADVANCED
K090539 · Respironics Inc., Sleep & Home Respiratory Group · Oct 2009