Cleared Traditional

K193056 - Puritan Bennett 980 Series Ventilator System (FDA 510(k) Clearance)

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

K193056 · Covidien, LLC · Anesthesiology device

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Nov 2020

Decision

385d

Days

Class 2

Risk

K193056 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, LLC (Boulder, US). The FDA issued a Cleared decision on November 20, 2020 after a review of 385 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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Submission Details

510(k) Number	K193056 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 01, 2019
Decision Date	November 20, 2020
Days to Decision	385 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

246d slower than avg

Panel avg: 139d · This submission: 385d

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.