# K934863: Flexsure HP

- Pathway: 510(k) (Traditional)
- Applicant: Smithkline Diagnostics, Inc.
- Decided: May 18, 1994 after 218 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K024350: Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device (2003), 1 descendant of its own
- K151935: Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only (2015), 0 descendants of its own
- K960183: Flexsure HP,Controls for Flexsurehp,Flexpack HP (Abbott Diagnostics)Andcontrols for Flexpack HP (Abbott Diagnostics) (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K934863
Methodology: https://510kreport.com/methodology