Cleared Traditional

Puritan Bennett 980 Series Ventilator System (K193056) - 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.

View all Covidien, LLC devices

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
245d slower than avg
Panel avg: 140d · 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.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 64
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K193056.
HAMILTON-C3
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K201658 · Hamilton Medical AG · Dec 2020
Servo-air 4.0 Ventilator System
K192604 · Maquet Critica Care AB · Jun 2020
Hamilton-G5
K193228 · Hamilton Medical AG · May 2020
Nihon Kohden NKV-550 Series Ventilator System
K192307 · Nihon Kohden Orangemed, Inc. · Jan 2020