Cleared Traditional

K193056 - Puritan Bennett 980 Series Ventilator S...

K193056 is an FDA 510(k) clearance for Puritan Bennett 980 Series Ventilator S..., manufactured by Covidien, LLC. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K193056 · Covidien, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K193056

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.

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 K193056.
HAMILTON-C3
K201306 · Hamilton Medical AG · Feb 2021
Ventway Sparrow
K202970 · Inovytech Medical Solutions , Ltd. · Jan 2021
Hamilton-C6
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