# K031024: Microlife Electronic Peak Flow Monitor, Model PF-100

- Pathway: 510(k) (Traditional)
- Applicant: Microlife Corp.
- Decided: Nov 14, 2003 after 228 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: 2 generations back to K943678 (1995). 2 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982995: Accutrax, Model EPF840, Korr Medical Technologies, Inc. (1998) Summary page 1.

## Most influential descendants
- K040723: Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software) (2004), 9 descendants of its own
- K152276: Wing Smart FEVI and Peak Flow Meter (2016), 4 descendants of its own
- K181666: Smart One (2018), 3 descendants of its own
- K193311: Aluna (2020), 1 descendant of its own
- K253180: Microlife Digital Peak Flow Meter, Model PF200B (PF200B) (2026), 0 descendants of its own

## Indications for use
This device is intended for monitoring PEF (Peak Expired Flow Rate) for patient home use. The device is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the device is used to monitor lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advice is required to understand the meaning and importance of the measurements reported by the device and how to decide on an appropriate treatment plan. This treatment plan will tell the patient what action to take when there are changes in their PEF measurements.

Source page: https://510kreport.com/device/K031024
Methodology: https://510kreport.com/methodology