Cleared Traditional

K083693 - PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083693 · Covidien, Formerly Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Apr 2009
Decision
111d
Days
Class 2
Risk

K083693 is an FDA 510(k) clearance for the PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Covidien, Formerly Nellcor Puritan Bennett, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 2, 2009 after a review of 111 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Covidien, Formerly Nellcor Puritan Bennett, Inc. devices

Submission Details

510(k) Number K083693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2008
Decision Date April 02, 2009
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 139d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 503
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