Cleared Special

K101130 - BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK (FDA 510(k) Clearance)

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

K101130 · Respironics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
133d
Days
Class 2
Risk

K101130 is an FDA 510(k) clearance for the BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK. 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 September 2, 2010 after a review of 133 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. 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. Standard predicate reliance. 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 K101130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2010
Decision Date September 02, 2010
Days to Decision 133 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 139d · This submission: 133d
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 46
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K101130.
myAir
K251889 · ResMed Corp · Apr 2026
BreathePal Bilevel (GFM50-MD2201)
K252078 · Compal Electronics, Inc. · Mar 2026
Mariana Minerva
K251661 · Resmed Pty , Ltd. · Feb 2026
Vivo 1, Vivo 2
K240778 · Breas Medical AB · Dec 2024
ReddyPort Elbow
K231064 · Smd Manufacturing, LLC · Jul 2023
BPAP System
K213169 · BMC Medical Co., Ltd. · Dec 2022