# K012928: Abi Vest Airway Clearance System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Respiratory
- Decided: Oct 9, 2001 after 39 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: 3 generations back to K884098 (1988). 3 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993629: Abi Vest Airway Clearance System, American Biosystems, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K063645: Frequencer, Model 1001 (2007), 3 descendants of its own
- K163378: Monarch Airway Clearance System (2017), 2 descendants of its own

## Indications for use
The intended use of the Advanced Respiratory modified Vest™ Airway Clearance System is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the 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 Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. The Advanced Respiratory modified Vest™ Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

Source page: https://510kreport.com/device/K012928
Methodology: https://510kreport.com/methodology