# K061875: Minispir; Spirolab Iii

- Pathway: 510(k) (Traditional)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Dec 11, 2006 after 161 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: 2 generations back to K013812 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052140: Spirolab, Spirolab II, Mir Medical Intl. Research Srl (2006) Summary page 1.

## Indications for use
The MIR Minispir spirometer and Spirolab III spirometer and pulse oximeter 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/K061875
Methodology: https://510kreport.com/methodology