# K181666: Smart One

- Pathway: 510(k) (Traditional)
- Applicant: Mir Medical International Research
- Decided: Aug 1, 2018 after 37 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- 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 K943678 (1995). 4 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K040723: Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software), Microlife Intellectual Property GmbH (2004) Summary page 4.

## Most influential descendants
- K193311: Aluna (2020), 1 descendant of its own
- K232588: Aluna 2 (2024), 0 descendants of its own
- K200832: Safey Peak Flow Meter (2020), 0 descendants of its own

## Indications for use
Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects.

Source page: https://510kreport.com/device/K181666
Methodology: https://510kreport.com/methodology