# K133051: Pulmone Minibox PFT TM

- Pathway: 510(k) (Traditional)
- Applicant: Pulmone Advanced Medical Devices, Ltd.
- Decided: May 2, 2014 after 217 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- 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 K013812 (2002). 7 ancestors in all.
3 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)
- K052328: Zan Lung-Function Lab, Zan Messgerate GmbH (2005) Summary page 1.
- K122384: Minispir, Mir Medical Intl. Research Srl (2012) Summary page 1.

## Most influential descendants
- 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 PulmOne MiniBoxPFT is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT is to be used by either a physician, respiratory therapist, or technician.

Source page: https://510kreport.com/device/K133051
Methodology: https://510kreport.com/methodology