Cleared Traditional

Puritan Bennett 980 Ventilator System (K162738) - FDA 510(k) Clearance

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

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.

View all Covidien devices

Submission Details

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.

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 63
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
AF541 SE Full Face Mask
K150638 · Respironics, Inc. · Sep 2015
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
K131252 · Covidien · Feb 2014
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · Respironics, Inc. · Jul 2012