Cleared Traditional

K092818 - BIPAP AVAPS VENTILATORY SUPPORT SYSTEM

K092818 is an FDA 510(k) clearance for BIPAP AVAPS VENTILATORY SUPPORT SYSTEM, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code MNS cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K092818 · Respironics, Inc. · Anesthesiology device
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Jan 2010
Decision
130d
Days
Class 2
Risk

K092818 is an FDA 510(k) clearance for the BIPAP AVAPS VENTILATORY SUPPORT SYSTEM. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 22, 2010 after a review of 130 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K092818

510(k) Number K092818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date January 22, 2010
Days to Decision 130 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
10d faster than avg
Panel avg: 140d · This submission: 130d
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 35
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K092818.
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
VPAP TX
K092186 · Resmed, Ltd. · Dec 2009
BIPAP SYNCHRONY 2
K092043 · Respironics, Inc. · Aug 2009
BIPAP AUTOSV
K063540 · Respironics, Inc. · Feb 2007