Cleared Traditional

K131252 - PURITAN BENNETT 980 SERIES VENTILATOR S...

K131252 is an FDA 510(k) clearance for PURITAN BENNETT 980 SERIES VENTILATOR S..., manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K131252 · Covidien · Anesthesiology device
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Feb 2014
Decision
298d
Days
Class 2
Risk

K131252 is an FDA 510(k) clearance for the PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on February 24, 2014 after a review of 298 days - an extended review cycle.

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.

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FDA 510(k) Submission Details - K131252

510(k) Number K131252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2013
Decision Date February 24, 2014
Days to Decision 298 days
Submission Type Traditional
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
158d slower than avg
Panel avg: 140d · This submission: 298d
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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K131252.
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K122438 · Hamilton Medical AG · Nov 2013
HAMILTON-G5
K131774 · Hamilton Medical AG · Oct 2013
HAMILTON-C3
K123637 · Hamilton Medical AG · Dec 2012