Cleared Traditional

K880721 - 6400ST INTERFACE MODULE-RS232

K880721 is an FDA 510(k) clearance for 6400ST INTERFACE MODULE-RS232, manufactured by Bird Products Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K880721 · Bird Products Corp. · Anesthesiology device
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Apr 1988
Decision
51d
Days
Class 2
Risk

K880721 is an FDA 510(k) clearance for the 6400ST INTERFACE MODULE-RS232. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bird Products Corp. (Palm Spring, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bird Products Corp. devices

FDA 510(k) Submission Details - K880721

510(k) Number K880721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1988
Decision Date April 14, 1988
Days to Decision 51 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
89d faster than avg
Panel avg: 140d · This submission: 51d
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 K880721.
BEAR 3 VENTILATOR
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MODEL 7200A, PRESSURE VENTILATION OPTION
K873151 · Puritan Bennett Corp. · May 1988
CPU 1100 VENTILATOR
K880054 · Ohmeda Medical · Apr 1988
GAMBRO-ENGSTROM ERICA IV RESPIRATOR
K872482 · Gambro, Inc. · Mar 1988
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K873215 · Puritan Bennett Corp. · Jan 1988
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
K870861 · Impact Instrumentation, Inc. · Jan 1988