# K122384: Minispir

- Pathway: 510(k) (Special)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Oct 4, 2012 after 59 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 K013812 (2002). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082766: Modification to Minispir, Spirolab Iii, Mir Medical Intl. Research Srl (2008) Summary page 1.

## Most influential descendants
- K133051: Pulmone Minibox PFT TM (2014), 3 descendants of its own
- K141793: Pulmone Miniboxpft 2.0 (2015), 2 descendants of its own
- K161295: MiniBox + (2016), 1 descendant of its own
- K240293: STS (2024), 0 descendants of its own

## Indications for use
The MIR Minispir and Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician. The devices are 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. They can be used in any setting.

Source page: https://510kreport.com/device/K122384
Methodology: https://510kreport.com/methodology