# K980550: Whistle Watch

- Pathway: 510(k) (Traditional)
- Applicant: Harwill Medical (Pty), Ltd.
- Decided: Aug 27, 1998 after 196 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Whistle Watch is a peak flow meter that has been designed to enable asthmatic children to check their respiratory status. Federal (USA) law restricts this device 10 sale by or on the order of a physician.

Source page: https://510kreport.com/device/K980550
Methodology: https://510kreport.com/methodology