Cleared Traditional

K881335 - BEAR 3 VENTILATOR

K881335 is an FDA 510(k) clearance for BEAR 3 VENTILATOR, manufactured by Bear Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K881335 · Bear Medical Systems, Inc. · Anesthesiology device
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Aug 1988
Decision
128d
Days
Class 2
Risk

K881335 is an FDA 510(k) clearance for the BEAR 3 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Riverside, US). The FDA issued a Cleared decision on August 4, 1988 after a review of 128 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 Bear Medical Systems, Inc. devices

FDA 510(k) Submission Details - K881335

510(k) Number K881335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1988
Decision Date August 04, 1988
Days to Decision 128 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
12d faster than avg
Panel avg: 140d · This submission: 128d
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 K881335.
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989
OHMEDA 7800 ANESTHESIA VENTILATOR
K883159 · Ohmeda Medical · Jun 1989
BEAR EVC-100 CONTROLLER
K882764 · Bear Medical Systems, Inc. · Sep 1988
MODEL 7200A, PRESSURE VENTILATION OPTION
K873151 · Puritan Bennett Corp. · May 1988
CPU 1100 VENTILATOR
K880054 · Ohmeda Medical · Apr 1988
6400ST INTERFACE MODULE-RS232
K880721 · Bird Products Corp. · Apr 1988