# K193610: BreathID Smart System

- Pathway: 510(k) (Special)
- Applicant: Exalenz Bioscience, Ltd.
- Decided: Feb 6, 2020 after 42 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: 6 generations back to K952220 (1996). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173777: BreathID Hp Lab System, Exalenz Bioscience, Ltd. (2018) Summary page 4.

## Most influential descendants
- K220494: BreathID Hp Lab System, BreathID Smart System (2022), 1 descendant of its own
- K223185: BreathID®  Smart System (2022), 0 descendants of its own

## Indications for use
The Exalenz BreathID® Hp Lab System or Exalenz BreathID® Smart System is intended for use to 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 Lab System or Exalenz BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The Exalenz BreathID® Hp Lab System consists of the appropriate IDkit Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application. The Exalenz BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device. To be administered by trained personnel as ordered by a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K193610
Methodology: https://510kreport.com/methodology