# K072979: Spirobank G

- Pathway: 510(k) (Special)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Dec 26, 2007 after 65 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: 4 generations back to K943404 (1994). 9 ancestors in all.
33 later devices descend from it; 7 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983909: Mir Spirobank Spirometer, Mir Medical Intl. Research Srl (1998) Summary page 1.
- K061712: Spirobank II, Mir Medical Intl. Research Srl (2006)

## Most influential descendants
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own
- K170798: Dictum Health (2017), 5 descendants of its own
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own

## Indications for use
The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting.

Source page: https://510kreport.com/device/K072979
Methodology: https://510kreport.com/methodology