# K130524: Breathid HP System

- Pathway: 510(k) (Traditional)
- Applicant: Exalenz Bioscience, Ltd.
- Decided: May 22, 2013 after 83 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: 3 generations back to K952220 (1996). 3 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K011668: Validation of the Breathid System, for the Detection of Helicbactor Pylori, Oridion Medical 1987, Ltd. (2001) Summary page 1.

## Most influential descendants
- 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
- K173772: BreathID Hp System (2018), 1 descendant of its own

## Indications for use
The Exalenz BreathlD® Hp System is intended for use to continually and non-invasively measure changes in the 1CO2 / 2CO 2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacterpylofl (H. pylon) infection in the stomach. The Exalenz BreathIDO Hp System is indicated for use as an aid in the initial diagnosis and post treatment. monitoring of H. pylori infection in adult patients. The Exalenz Breathlo® Hp System consists of the lDkit:Hp m and the BreathlD® Hp test device. The device is for use by trained health care professionals. To be administered under a physician's supervision.

Source page: https://510kreport.com/device/K130524
Methodology: https://510kreport.com/methodology