Cleared Special

K082966 - PB 540 VENTILATOR

K082966 is an FDA 510(k) clearance for PB 540 VENTILATOR, manufactured by Covidien, Formerly Nellcor Puritan Bennett, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 25-day FDA review.

K082966 · Covidien, Formerly Nellcor Puritan Bennett, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Oct 2008
Decision
25d
Days
Class 2
Risk

K082966 is an FDA 510(k) clearance for the PB 540 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Covidien, Formerly Nellcor Puritan Bennett, Inc. (Boulder, US). The FDA issued a Cleared decision on October 31, 2008 after a review of 25 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 Covidien, Formerly Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K082966

510(k) Number K082966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2008
Decision Date October 31, 2008
Days to Decision 25 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
115d faster than avg
Panel avg: 140d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
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 - CBK Ventilator, Continuous, Facility Use

All 250
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K082966.
HAMILTON-C2
K090468 · Hamilton Medical AG · Jun 2009
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · Fisher &Paykel Healthcare , Ltd. · Mar 2009
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
K071526 · Impact Instrumentation, Inc. · Dec 2008
ENGSTROM CARESTATION, ENGSTROM PRO
K081842 · Datex-Ohmeda, Inc. · Oct 2008
MODIFICATION TO HAMILTON-G5
K081521 · Hamilton Medical AG · Sep 2008
MODIFICATION TO GALILEO GOLD
K080181 · Hamilton Medical AG · Jun 2008