# K994074: Tri-Ball

- Pathway: 510(k) (Traditional)
- Applicant: Leventon, S.A.
- Decided: Jun 8, 2000 after 189 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The TRI-BALL is an incentive spirometer, in other words, a respiratory exerciser, that indicates a patient’s inspiratory flow rate and that provides an incentive to the patient to improve his or her ventilation.

Source page: https://510kreport.com/device/K994074
Methodology: https://510kreport.com/methodology