Cleared Traditional

K884098 - THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884098 · American Biosystems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
60d faster than avg
Panel avg: 139d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K884098.
AffloVest® Mobile Airway Clearance Therapy
K252849 · Tactile Medical · Apr 2026
BreatheBand® (Model 1000)
K250860 · Exemplar Medical, LLC · Oct 2025
LibAirty Airway Clearance System
K242063 · Synchrony Medical , Ltd. · Dec 2024
Respiratory Muscle Trainer
K240959 · Chongqing Moffy Innovation Technology Co., Ltd. · Dec 2024
The Vest APX System (PVAPX1)
K233441 · Baxter Healthcare Corportation · Mar 2024
Electromed SmartVest Airway Clearance System
K222496 · Electromed, Inc. · Nov 2022