# K141793: Pulmone Miniboxpft 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Pulmone Advanced Medical Devices, Ltd.
- Decided: Mar 6, 2015 after 247 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: 5 generations back to K013812 (2002). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133051: Pulmone Minibox PFT TM, Pulmone Advanced Medical Devices, Ltd. (2014) Summary page 4.

## Most influential descendants
- K161295: MiniBox + (2016), 1 descendant of its own
- K240293: STS (2024), 0 descendants of its own

## Indications for use
The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician.

Source page: https://510kreport.com/device/K141793
Methodology: https://510kreport.com/methodology