# K161676: Q13 Spirolyser®

- Pathway: 510(k) (Traditional)
- Applicant: Fim Medical
- Decided: Oct 20, 2016 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 K010761 (2002). 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)
- K010761: SPL-50 Spirolyser, Fim Medical (2002) Summary page 4.

## Indications for use
Intended to perform spirometry in hospital and clinical environments, for adult patients and pediatric patients aged 6 years and above.

Source page: https://510kreport.com/device/K161676
Methodology: https://510kreport.com/methodology