Cleared Traditional

K921387 - BIRD 8400ST ADULT VOLUME VENTILATOR

K921387 is the FDA 510(k) clearance for BIRD 8400ST ADULT VOLUME VENTILATOR by Bird Products Corp.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K921387 · Bird Products Corp. · Anesthesiology device
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Mar 1993
Decision
353d
Days
Class 2
Risk

K921387 is an FDA 510(k) clearance for the BIRD 8400ST ADULT VOLUME VENTILATOR. 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 March 11, 1993 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bird Products Corp. devices

Submission Details

510(k) Number K921387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1992
Decision Date March 11, 1993
Days to Decision 353 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 140d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 121
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K921387.
PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD
K930017 · Puritan Bennett Corp. · Sep 1994
PROPORTIONAL SOLENOID VALVE
K922102 · Puritan Bennett Corp. · Sep 1994
POWER PACK 350/BATTERY PACK 351
K923992 · Siemens Medical Solutions USA, Inc. · Apr 1993
SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K925262 · Merit Medical Systems, Inc. · Jan 1993
MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50
K920002 · Puritan Bennett Corp. · Nov 1992