Cleared Traditional

K162738 - Puritan Bennett 980 Ventilator System

K162738 is an FDA 510(k) clearance for Puritan Bennett 980 Ventilator System, manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K162738 · Covidien · Anesthesiology device
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Oct 2017
Decision
392d
Days
Class 2
Risk

K162738 is an FDA 510(k) clearance for the Puritan Bennett 980 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 October 27, 2017 after a review of 392 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.

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FDA 510(k) Submission Details - K162738

510(k) Number K162738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date October 27, 2017
Days to Decision 392 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
252d slower than avg
Panel avg: 140d · This submission: 392d
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 K162738.
TV-100
K173973 · Bio-Med Devices, Inc. · Jul 2018
Astral 100/150
K172875 · Resmed, Ltd. · Apr 2018
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
K173060 · Fisher and Paykel Healthcare Limited · Jan 2018
731 Series Ventilators
K162832 · ZOLL Medical Corporation · Aug 2017
HAMILTON-C3
K161450 · Hamilton Medical AG · Apr 2017
HAMILTON-MR1
K153046 · Hamilton Medical AG · Sep 2016