# K130784: Spirotel

- Pathway: 510(k) (Special)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Oct 30, 2013 after 223 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: 3 generations back to K943404 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043528: Spirotel, Mir Medical Intl. Research Srl (2005) Summary page 1.

## Indications for use
The Spirotel spirometer and pulse oxinrieter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.

Source page: https://510kreport.com/device/K130784
Methodology: https://510kreport.com/methodology