Cleared Special

K984535 - PURITAN-BENNETT 840 VENTILATORY SYSTEM ...

K984535 is an FDA 510(k) clearance for PURITAN-BENNETT 840 VENTILATORY SYSTEM ..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 7-day FDA review.

K984535 · Puritan Bennett Corp. · Anesthesiology device
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Dec 1998
Decision
7d
Days
Class 2
Risk

K984535 is an FDA 510(k) clearance for the PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on December 28, 1998 after a review of 7 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 Corp. devices

FDA 510(k) Submission Details - K984535

510(k) Number K984535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 21, 1998
Decision Date December 28, 1998
Days to Decision 7 days
Submission Type Special
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
133d faster than avg
Panel avg: 140d · This submission: 7d
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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K984535.
MILLENNIUM INFANT VENTILATOR
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BEAR CUB 750 PSV
K992788 · Bear Medical Systems, Inc. · Sep 1999
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
K984379 · Puritan Bennett Corp. · Dec 1998
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
K983981 · Bear Medical Systems, Inc. · Nov 1998
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998