Cleared Abbreviated

BIPAP AUTOSV (K063540) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K063540 · Respironics, Inc. · Anesthesiology device
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Feb 2007
Decision
90d
Days
Class 2
Risk

K063540 is an FDA 510(k) clearance for the BIPAP AUTOSV. 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 February 22, 2007 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 868.5895 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Respironics, Inc. devices

Submission Details

510(k) Number K063540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2006
Decision Date February 22, 2007
Days to Decision 90 days
Submission Type Abbreviated
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
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 19
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K063540.
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
K101130 · Respironics, Inc. · Sep 2010
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K092818 · Respironics, Inc. · Jan 2010
BIPAP SYNCHRONY 2
K092043 · Respironics, Inc. · Aug 2009
BIPAP SYNCHRONY
K063533 · Respironics, Inc. · Feb 2007
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
K031656 · Respironics, Inc. · Jul 2003
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
K020777 · Respironics, Inc. · Mar 2002