Cleared Special

K984379 - NELLCOR PURITAN BENNETT

K984379 is an FDA 510(k) clearance for NELLCOR PURITAN BENNETT, 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 3-day FDA review.

K984379 · Puritan Bennett Corp. · Anesthesiology device
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Dec 1998
Decision
3d
Days
Class 2
Risk

K984379 is an FDA 510(k) clearance for the NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Galway, IE). The FDA issued a Cleared decision on December 10, 1998 after a review of 3 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 - K984379

510(k) Number K984379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date December 10, 1998
Days to Decision 3 days
Submission Type Special
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
137d faster than avg
Panel avg: 140d · This submission: 3d
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 K984379.
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
K992670 · Instrumentation Industries, Inc. · Sep 1999
BEAR CUB 750 PSV
K992788 · Bear Medical Systems, Inc. · Sep 1999
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K984535 · 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
BIRD MONITOR INTERFACE
K982580 · Bird Products Corp. · Oct 1998