Cleared Special

K021573 - PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION

K021573 is an FDA 510(k) clearance for PURITAN-BENNETT 840 VENTILATIOR SYSTEM ..., manufactured by Puritan-Bennett. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 91-day FDA review.

K021573 · Puritan-Bennett · Anesthesiology device
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Aug 2002
Decision
91d
Days
Class 2
Risk

K021573 is an FDA 510(k) clearance for the PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan-Bennett (Carlsbad, US). The FDA issued a Cleared decision on August 13, 2002 after a review of 91 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Puritan-Bennett devices

FDA 510(k) Submission Details - K021573

510(k) Number K021573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received May 14, 2002
Decision Date August 13, 2002
Days to Decision 91 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

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 357
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K021573.
IMAGE3 SE DISPOSABLE FULL FACE MASK
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AVEA
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K020746 · Bird Products Corp. · Apr 2002
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K010925 · Siemens Elema AB · Dec 2001