# K010009: Koko Peak KP; Koko Peak KP+

- Pathway: 510(k) (Abbreviated)
- Applicant: Pds Healthcare Products, Inc.
- Decided: Jun 1, 2001 after 150 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K092335: Peak Expiratory Flow Meter, KN-9710 (2010), 0 descendants of its own
- K013489: KP + LFM (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K010009
Methodology: https://510kreport.com/methodology