Cleared Special

K992788 - BEAR CUB 750 PSV

K992788 is an FDA 510(k) clearance for BEAR CUB 750 PSV, manufactured by Bear Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 28-day FDA review.

K992788 · Bear Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Sep 1999
Decision
28d
Days
Class 2
Risk

K992788 is an FDA 510(k) clearance for the BEAR CUB 750 PSV. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Palm Spring, US). The FDA issued a Cleared decision on September 16, 1999 after a review of 28 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 Bear Medical Systems, Inc. devices

FDA 510(k) Submission Details - K992788

510(k) Number K992788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1999
Decision Date September 16, 1999
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 K992788.
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
K990177 · Nellcor Puritan Bennett, Inc. · Nov 1999
MILLENNIUM INFANT VENTILATOR
K993167 · Sechrist Industries, Inc. · Nov 1999
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
K992670 · Instrumentation Industries, Inc. · Sep 1999
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K984535 · Puritan Bennett Corp. · Dec 1998
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