Cleared Traditional

K897113 - PURITAN-BENNETT COMPANION 2801 VOLUME V...

K897113 is an FDA 510(k) clearance for PURITAN-BENNETT COMPANION 2801 VOLUME V..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K897113 · Puritan Bennett Corp. · Anesthesiology device
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Mar 1990
Decision
90d
Days
Class 2
Risk

K897113 is an FDA 510(k) clearance for the PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on March 26, 1990 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K897113

510(k) Number K897113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date March 26, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K897113.
MODEL LP6 VENTILATOR, MODIFICATION
K905244 · Aequitron Medical, Inc. · Nov 1990
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990
BEAR CEM CONTROLLER
K900637 · Bear Medical Systems, Inc. · Aug 1990
MODIFIED 225/SIMV VOLUME VENTILATOR
K884389 · Monaghan Medical Corp. · Mar 1990
V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR
K895541 · Bird Products Corp. · Mar 1990
TYPE 9290 INTERFACE RESPIRATOR
K896735 · S & W Medico Teknik · Feb 1990