# K050424: Ergofilter Spi Accessory to Spirolyser SPL-50

- Pathway: 510(k) (Traditional)
- Applicant: Fim Medical
- Decided: Jun 23, 2005 after 125 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- 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 K934509 (1993). 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)
- K934509: Pulmoguard Disposable Baterial/Viral Filter, Sdi Diagnostics, Inc. (1993) Summary page 1.

## Indications for use
Intended to perform spirometry and may be used in hospitals and medical offices or at other locations including homes. The accessory is a Bacterial/Viral Filter designed for single patient use. For use on both adult and pediatric patients.

Source page: https://510kreport.com/device/K050424
Methodology: https://510kreport.com/methodology