Cleared Traditional

K151252 - Puritan Bennett 840 Series Ventilator S...

K151252 is an FDA 510(k) clearance for Puritan Bennett 840 Series Ventilator S..., manufactured by Covidien LP. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K151252 · Covidien LP · Anesthesiology device
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Mar 2016
Decision
322d
Days
Class 2
Risk

K151252 is an FDA 510(k) clearance for the Puritan Bennett 840 Series Ventilator System. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Covidien LP (Boulder, US). The FDA issued a Cleared decision on March 29, 2016 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 LP devices

FDA 510(k) Submission Details - K151252

510(k) Number K151252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2015
Decision Date March 29, 2016
Days to Decision 322 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
182d slower than avg
Panel avg: 140d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 324
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K151252.
HAMILTON-C3
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SERVO-U Ventilator System, SERVO-n Ventilator System
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AirView
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AF541 SE Full Face Mask
K150638 · Respironics, Inc. · Sep 2015