# K053156: Mini-Wright Digital, Model 3120001

- Pathway: 510(k) (Traditional)
- Applicant: Clement Clarke Intl., Ltd.
- Decided: Jan 31, 2006 after 78 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: 1 generation back to K980951 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980951: Oneflow, Sti Medical (2000)

## Indications for use
The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEVi monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. The device is intended for use with paediatric and adult patients in both home and clinical settings.

Source page: https://510kreport.com/device/K053156
Methodology: https://510kreport.com/methodology