# K173772: BreathID Hp System

- Pathway: 510(k) (Traditional)
- Applicant: Exalenz Bioscience, Ltd.
- Decided: Mar 8, 2018 after 86 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: 4 generations back to K952220 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130524: Breathid HP System, Exalenz Bioscience, Ltd. (2013) Summary page 5.

## Most influential descendants
- K221896: BreathID Hp System (2022), 0 descendants of its own

## Indications for use
The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the 13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The Exalenz BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The Exalenz BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® 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/K173772
Methodology: https://510kreport.com/methodology