# KHE: Reagent, Occult Blood

- Device class: 2; regulation: 21 CFR 864.6550; FDA's rule: 510(k) required
- FDA decisions: 97
- Recalls: 13 (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)
- 2005: 1
- 2006: 5
- 2007: 3
- 2008: 3
- 2010: 2
- 2011: 2
- 2012: 2
- 2015: 1
- 2017: 4
- 2018: 1

## Most-cited predicates
- K021423: Instant-View Fecal Occult Blood Rapid Test (2002), cited by 3
- K041297: Polymedco OC Light Fobt Test (2004), cited by 2
- K880499: Hemoccult Sensitive Test (1988), cited by 2
- K070660: Instant-View Fecal Occult Blood (Fob) Rapid Test (2007), cited by 2
- K041202: Hemosure One-Step Fecal Occult Blood Test (2004), cited by 1
- K102664: Hema Screen ER (2011), cited by 1
- K060463: Hema Screen Specific Ifobt (2006), cited by 1
- K110309: Fob One Step Rapid Test (2011), cited by 1
- K080812: Hemoccult Ict (2008), cited by 1

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