# K161295: MiniBox +

- Pathway: 510(k) (Traditional)
- Applicant: Pulmone Advanced Medical Devices, Ltd.
- Decided: Oct 21, 2016 after 165 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: 6 generations back to K013812 (2002). 9 ancestors in all.
1 later device descends 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)
- K141793: Pulmone Miniboxpft 2.0, Pulmone Advanced Medical Devices, Ltd. (2015) Summary page 4.
- K052328: Zan Lung-Function Lab, Zan Messgerate GmbH (2005) Summary page 4.

## Most influential descendants
- K240293: STS (2024), 0 descendants of its own

## Indications for use
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting

Source page: https://510kreport.com/device/K161295
Methodology: https://510kreport.com/methodology