Cleared Special

K082237 - PURITAN BENNETT

K082237 is an FDA 510(k) clearance for PURITAN BENNETT, manufactured by Mallinckrodt Developpement France. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 63-day FDA review.

K082237 · Mallinckrodt Developpement France · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
63d
Days
Class 2
Risk

K082237 is an FDA 510(k) clearance for the PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Mallinckrodt Developpement France (Boulder, US). The FDA issued a Cleared decision on October 9, 2008 after a review of 63 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 Mallinckrodt Developpement France devices

FDA 510(k) Submission Details - K082237

510(k) Number K082237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2008
Decision Date October 09, 2008
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
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 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K082237.
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K081029 · Fisher &Paykel Healthcare , Ltd. · Sep 2008
COMFORTGEL FULL FACE MASK
K073600 · Respironics Inc., Sleep & Home Respiratory Group · Apr 2008