# K952220: Meretek Breath Test for H.Pylori Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Meretek Diagnostics, Inc.
- Decided: Sep 17, 1996 after 495 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.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K972352: The Meretek Ubt Breath Test for H.Pylori (1997), 9 descendants of its own
- K011668: Validation of the Breathid System, for the Detection of Helicbactor Pylori (2001), 8 descendants of its own
- K130524: Breathid HP System (2013), 7 descendants of its own
- K162150: BreathID Hp Lab System (2016), 4 descendants of its own
- K173777: BreathID Hp Lab System (2018), 3 descendants of its own

Source page: https://510kreport.com/device/K952220
Methodology: https://510kreport.com/methodology