# K880499: Hemoccult Sensitive Test

- Pathway: 510(k) (Traditional)
- Applicant: Smithkline Diagnostics, Inc.
- Decided: May 23, 1988 after 108 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K070660: Instant-View Fecal Occult Blood (Fob) Rapid Test (2007), 3 descendants of its own
- K021423: Instant-View Fecal Occult Blood Rapid Test (2002), 3 descendants of its own
- K110309: Fob One Step Rapid Test (2011), 1 descendant of its own
- K173212: Instant-view-PLUS immunochemical Fecal Occult Blood Test (2018), 0 descendants of its own
- K162333: Wondfo One Step Fecal Occult Blood (FOB) Test (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K880499
Methodology: https://510kreport.com/methodology