# K965192: Thairapy Vest System

- Pathway: 510(k) (Traditional)
- Applicant: American Biosystems, Inc.
- Decided: Jun 24, 1997 after 182 days
- Product code: BYI (Percussor, Powered-Electric)
- Device class: 2
- Regulation: 21 CFR 868.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884098 (1988). 1 ancestor in all.
23 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884098: Thairapy (TM) Bronchial Drainage System, Model 101, American Biosystems, Inc. (1988) Summary page 1.

## Most influential descendants
- K993629: Abi Vest Airway Clearance System (2000), 19 descendants of its own
- K012928: Abi Vest Airway Clearance System (2001), 18 descendants of its own
- K024309: The Vest Airway Clearance System, Model 104 (2003), 13 descendants of its own
- K142482: The Vest Airway Clearance System (2015), 5 descendants of its own
- K122111: Respironics Simplyclear Device (2012), 4 descendants of its own

## Indications for use
The intended ase of the modified ThAIRapy® Vest is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practice Guidelines for Postural Drainage Therapy.' According to AARC guidelines, the goals of airway clearance therapy are to improve mobilization of bronchial secretions, match ventilation and perfusion, and normalize functional residual capacity. Specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with secretion clearance, or presence of atelectasis caused by mucus plugging.

Source page: https://510kreport.com/device/K965192
Methodology: https://510kreport.com/methodology