# K031356: Hemaprompt Gastric

- Pathway: 510(k) (Traditional)
- Applicant: Aerscher Diagnostics
- Decided: Sep 24, 2003 after 166 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
HemaPrompt Gastric is a guaiac-based in-vitro method for the qualitative detection of occult blood in gastric aspirate or vomitus by medical professionals only. A separate segment of pH paper is provided on the slide for estimation of pH of the gastric juice It is used for the early detection of occult blood in such conditions as gastric trauma, gastric or duodenal ulceration, gastric cancer, esophageal varices, situations of exogenous or endogenous gastritis, leukemia, and hereditary telangiectasia. These conditions may be encountered in the emergency room, recovery room or intensive care.

Source page: https://510kreport.com/device/K031356
Methodology: https://510kreport.com/methodology