# K061712: Spirobank II

- Pathway: 510(k) (Traditional)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Dec 1, 2006 after 165 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). 8 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 49 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.
- K043528: Spirotel, Mir Medical Intl. Research Srl (2005) Summary page 1.

## Most influential descendants
- K072979: Spirobank G (2007), 33 descendants of its own
- 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

## Indications for use
The Spirobank II spirometer and pulse oximeter 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 * oximetry testing in people of all ages. It can be used in any setting.

Source page: https://510kreport.com/device/K061712
Methodology: https://510kreport.com/methodology