# K053149: Spiro-Ball

- Pathway: 510(k) (Traditional)
- Applicant: Leventon, S.A.
- Decided: Dec 13, 2005 after 33 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
Longest line of descent: 1 generation back to K970596 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970596: DHD Emerald Product, Dhd Diemolding Healthcare Div. (1997) Summary page 1.

## Indications for use
The Spiro-Ball is a product for use in respiratory therapy and for adult people. It is intended for a single patient use, and it can be used both in the medical center and out of it (homecare therapies).

Source page: https://510kreport.com/device/K053149
Methodology: https://510kreport.com/methodology