# K953686: Helisal Rapid Blood Test

- Pathway: 510(k) (Traditional)
- Applicant: Cortecs, Ltd.
- Decided: May 21, 1996 after 295 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973523: Accustat H. Pylori One Step Test (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K953686
Methodology: https://510kreport.com/methodology