Cleared Special

K052110 - M-SERIES PRO CPAP SYTEM

K052110 is an FDA 510(k) clearance for M-SERIES PRO CPAP SYTEM, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 77-day FDA review.

K052110 · Respironics, Inc. · Anesthesiology device
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Oct 2005
Decision
77d
Days
Class 2
Risk

K052110 is an FDA 510(k) clearance for the M-SERIES PRO CPAP SYTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 20, 2005 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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

FDA 510(k) Submission Details - K052110

510(k) Number K052110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2005
Decision Date October 20, 2005
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K052110.
COMFORTLITE NASAL MASK
K053352 · Respironics, Inc. · Feb 2006
RES TRAXX DATA CENTER
K053205 · Resmed, Ltd. · Feb 2006
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
K051226 · Cardinalhealth · Nov 2005
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K050994 · Cardinalhealth · Aug 2005
RES TRAXX DATA CENTER
K051314 · Resmed, Ltd. · Jul 2005
BIPAP AUTO
K050759 · Respironics, Inc. · Jun 2005