# K013489: KP + LFM

- Pathway: 510(k) (Traditional)
- Applicant: Pds Healthcare Products, Inc.
- Decided: Nov 29, 2001 after 38 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 K010009 (2001). 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)
- K010009: Koko Peak KP; Koko Peak KP+, Pds Healthcare Products, Inc. (2001) Summary page 1.

## Indications for use
For personal monitoring of expiratory-breath function at home under direction of a physician. It measures, logs, and reports events related to respiration and the spirometric values of peak expiratory flow (PEF), zone and percent of PEF compared to a reference value, timed forced expiratory volumes over 1 second (FEV1) and 6 seconds (FEV6), and the ratio of FEV1/FEV6.

Source page: https://510kreport.com/device/K013489
Methodology: https://510kreport.com/methodology