Cleared Traditional

K884722 - LUMINEB I

K884722 is an FDA 510(k) clearance for LUMINEB I, manufactured by Lumiscope Co., Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K884722 · Lumiscope Co., Inc. · Anesthesiology device
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Feb 1989
Decision
85d
Days
Class 2
Risk

K884722 is an FDA 510(k) clearance for the LUMINEB I. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Lumiscope Co., Inc. (Edison, US). The FDA issued a Cleared decision on February 3, 1989 after a review of 85 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 Lumiscope Co., Inc. devices

FDA 510(k) Submission Details - K884722

510(k) Number K884722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1988
Decision Date February 03, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 33
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K884722.
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MAXI COMPRESSORS
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ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER
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K864547 · Bird Products Corp. · Jan 1987