Cleared Traditional

K864547 - BIRD 6500 AIR COMPRESSOR

K864547 is an FDA 510(k) clearance for BIRD 6500 AIR COMPRESSOR, manufactured by Bird Products Corp.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K864547 · Bird Products Corp. · Anesthesiology device
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Jan 1987
Decision
54d
Days
Class 2
Risk

K864547 is an FDA 510(k) clearance for the BIRD 6500 AIR COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Bird Products Corp. (Palm Spring, US). The FDA issued a Cleared decision on January 12, 1987 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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 - K864547

510(k) Number K864547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date January 12, 1987
Days to Decision 54 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
86d faster than avg
Panel avg: 140d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 - BTI Compressor, Air, Portable

All 19
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K864547.
NEBULIZER SYSTEM
K922623 · Healthdyne, Inc. · Dec 1992
PM14 SOFT AIR COMPRESSOR
K902762 · Precision Medical, Inc. · Jul 1990
SIEMENS DRY AIR COMPRESSOR
K871829 · Siemens Elema AB · Jun 1987
OHMEDA CPU AIR COMPRESSOR MODEL 3350
K854306 · Ohmeda Medical · Nov 1985
AIR COMPRESSOR
K850795 · Bear Medical Systems, Inc. · May 1985
IMPACT MODEL 601
K841537 · Impact Instrumentation, Inc. · May 1984