Cleared Traditional

K884098 - THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101

K884098 is an FDA 510(k) clearance for THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, manufactured by American Biosystems, Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K884098 · American Biosystems, Inc. · Anesthesiology device
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Dec 1988
Decision
79d
Days
Class 2
Risk

K884098 is an FDA 510(k) clearance for the THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by American Biosystems, Inc. (Marine On St. Croix, US). The FDA issued a Cleared decision on December 16, 1988 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - 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 American Biosystems, Inc. devices

FDA 510(k) Submission Details - K884098

510(k) Number K884098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1988
Decision Date December 16, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 140d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
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 - BYI Percussor, Powered-electric

All 22
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K884098.
THAIRAPY VEST SYSTEM
K965192 · American Biosystems, Inc. · Jun 1997
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FLEX-CUP PERCUSSOR
K892862 · Life Design Systems, Inc. · May 1989
MANUAL PERCUSSOR CUPS
K883899 · Medical Components, Inc. · Dec 1988
SALTER LABS 3000 SERIES PERCUSSORS
K863658 · Salter Labs · Oct 1986
NEONATE PERCUSSOR
K860510 · Ballard Medical Products · Feb 1986