# KHP: Acid, Lactic, Enzymatic Method

- Device class: 1; regulation: 21 CFR 862.1450; FDA's rule: 510(k) exempt
- FDA decisions: 27
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1993: 1
- 1995: 2
- 1997: 1
- 1998: 2
- 2001: 1
- 2002: 1
- 2010: 1
- 2011: 2
- 2012: 2
- 2013: 1

## Most-cited predicates
- K093297: Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube (2010), cited by 2
- K982071: I-Stat Lactate Test (1998), cited by 2
- K011478: I-Stat System (2001), cited by 1
- K914508: Dimension (R) Lactic Acid Method (1991), cited by 1
- K100602: Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips (2011), cited by 1
- K951331: Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor (1995), cited by 1
- K980908: Lactate Pro System (1998), cited by 1

Source page: https://510kreport.com/product-code/KHP
Data by year (CSV): https://510kreport.com/product-code/KHP.csv