Cleared Traditional

K920113 - BIRD GRAPHICS MONITOR

K920113 is an FDA 510(k) clearance for BIRD GRAPHICS MONITOR, 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 406-day FDA review.

K920113 · Bird Products Corp. · Anesthesiology device
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Feb 1993
Decision
406d
Days
Class 2
Risk

K920113 is an FDA 510(k) clearance for the BIRD GRAPHICS MONITOR. 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 February 19, 1993 after a review of 406 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Bird Products Corp. devices

FDA 510(k) Submission Details - K920113

510(k) Number K920113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1992
Decision Date February 19, 1993
Days to Decision 406 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 140d · This submission: 406d
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 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K920113.
POWER PACK 350/BATTERY PACK 351
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SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K925262 · Merit Medical Systems, Inc. · Jan 1993
VENTILATOR INTERFACE 9291/4
K922314 · S & W Medico Teknik · Dec 1992
VENTILATOR ADULT STAR MODIFICATION
K922654 · Infrasonics Corp. · Dec 1992