# K101380: Rxpeakflow

- Pathway: 510(k) (Traditional)
- Applicant: Noble Marketing
- Decided: Sep 13, 2010 after 119 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 K781922 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030586: Micropeak, Micro Direct, Inc. (2003) Summary page 1.

## Indications for use
The RxPeakFlow is a single patient use device to measure a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flaw rate. It is a single patient use device intended for use for children to adults.

Source page: https://510kreport.com/device/K101380
Methodology: https://510kreport.com/methodology