# K980908: Lactate Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Kdk Corp.
- Decided: Sep 11, 1998 after 185 days
- Product code: KHP (Acid, Lactic, Enzymatic Method)
- Device class: 1
- Regulation: 21 CFR 862.1450
- 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 K913806 (1991). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951331: Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor, Boehringer Mannheim Corp. (1995) Summary page 4.
- K913806: Ysi Model 2300 Stat Plus, Ysis, Inc. (1991) Summary page 4.

## Most influential descendants
- K100602: Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips (2011), 1 descendant of its own
- K112955: Nova Statstrip Lactate Hospital Meter System (2012), 0 descendants of its own

## Indications for use
The Lactate Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the home and in the clinical setfing.

Source page: https://510kreport.com/device/K980908
Methodology: https://510kreport.com/methodology