# JPI: Device, Hematocrit Measuring

- Device class: 2; regulation: 21 CFR 864.6400; FDA's rule: 510(k) exempt
- FDA decisions: 15
- Recalls: 9 (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)
- 1982: 1
- 1983: 3
- 1984: 1
- 1985: 3
- 1987: 1
- 1990: 2
- 1993: 1
- 1995: 1
- 2017: 1
- 2020: 1

## Most-cited predicates
- K183680: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), cited by 1
- K950942: Crit-Line Hematocrit Alert (1995), cited by 1
- K924167: Crit-Line (1993), cited by 1
- K163342: i-STAT Hematocrit test with i-STAT Alinity System (2017), cited by 1

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