# K011668: Validation of the Breathid System, for the Detection of Helicbactor Pylori

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Jul 9, 2001 after 53 days
- Product code: MSQ (Test, Urea (Breath Or Blood))
- 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
Longest line of descent: 2 generations back to K952220 (1996). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972352: The Meretek Ubt Breath Test for H.Pylori, Meretek Diagnostics, Inc. (1997) Summary page 4.
- K952220: Meretek Breath Test for H.Pylori Collection Kit, Meretek Diagnostics, Inc. (1996) Summary page 4.
- (no number) CLOtest®: named in the summary without a submission number

## Most influential descendants
- 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
- K193610: BreathID Smart System (2020), 2 descendants of its own
- K220494: BreathID Hp Lab System, BreathID Smart System (2022), 1 descendant of its own

## Indications for use
The BreathID™ System is used to diagnose and monitor Helicobacter pylori infection by measunng changes in the *CO,/?CO, ratio in a patient’s breath following the ingestion of "°C urea. The Oridion BreathID™ system continually and non-invasively measures changes in the "*C0,/"?!CO, exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori infection in the stomach. The Oridion BreathID™ System is to be used as an aid for initial diagnosis and post treatment monitoring of Helicobacter pylori infection.

Source page: https://510kreport.com/device/K011668
Methodology: https://510kreport.com/methodology