Cleared Special

BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX (K020777) - FDA 510(k) Clearance

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

K020777 · Respironics, Inc. · Anesthesiology device
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Mar 2002
Decision
9d
Days
Class 2
Risk

K020777 is an FDA 510(k) clearance for the BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX. 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 March 20, 2002 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respironics, Inc. devices

Submission Details

510(k) Number K020777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2002
Decision Date March 20, 2002
Days to Decision 9 days
Submission Type Special
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
131d faster than avg
Panel avg: 140d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

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 K020777.
BIPAP AUTOSV
K063540 · Respironics, Inc. · Feb 2007
BIPAP SYNCHRONY
K063533 · Respironics, Inc. · Feb 2007
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
K031656 · Respironics, Inc. · Jul 2003
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
K012323 · Respironics, Inc. · Dec 2001
BIPAP SYNCHRONY HC
K992530 · Respironics, Inc. · Mar 2000
BIPAP HARMONY S/T, MODEL 1001445
K984407 · Respironics, Inc. · May 1999