510(k) · Cleared
ClearedBreathID® Smart System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience Israel, Ltd. · MSQ Test, Urea (Breath Or Blood)
Cleared on Nov 10, 2022 as substantially equivalent to K220494 (Meridian Bioscience Israel, Ltd., 2022) after a 29-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Nov 10, 2022
- Review
- 29 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K952220 (1996). No later device cites it as a predicate yet.
- Root · 8 generations backK952220 Meretek Breath Test for H.Pylori Collection KitMeretek Diagnostics, Inc. · 1996
- 7 generations backK972352 The Meretek Ubt Breath Test for H.PyloriMeretek Diagnostics, Inc. · 1997
- 6 generations backK011668 Validation of the Breathid System, for the Detection of Helicbactor…Oridion Medical 1987, Ltd. · 2001
- 5 generations backK130524 Breathid HP SystemExalenz Bioscience, Ltd. · 2013
- 4 generations backK162150 BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2016
- 3 generations backK173777 BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2018
- 2 generations backK193610 BreathID Smart SystemExalenz Bioscience, Ltd. · 2020
- 1 generation backK220494 BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd. · 2022
- This deviceK223185 BreathID® Smart SystemMeridian Bioscience Israel, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952220 | Meretek Breath Test for H.Pylori Collection Kit | Meretek Diagnostics, Inc. | 1996 | — |
| −7 | K972352 | The Meretek Ubt Breath Test for H.Pylori | Meretek Diagnostics, Inc. | 1997 | — |
| −6 | K011668 | Validation of the Breathid System, for the Detection of Helicbactor Pylori | Oridion Medical 1987, Ltd. | 2001 | — |
| −5 | K130524 | Breathid HP System | Exalenz Bioscience, Ltd. | 2013 | — |
| −4 | K162150 | BreathID Hp Lab System | Exalenz Bioscience, Ltd. | 2016 | — |
| −3 | K173777 | BreathID Hp Lab System | Exalenz Bioscience, Ltd. | 2018 | — |
| −2 | K193610 | BreathID Smart System | Exalenz Bioscience, Ltd. | 2020 | — |
| −1 | K220494 | BreathID Hp Lab System, BreathID Smart System | Meridian Bioscience Israel, Ltd. | 2022 | — |
| 0 (this device) | K223185 | BreathID® Smart System | Meridian Bioscience Israel, Ltd. | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSQ device
- #1 K220494 BreathID Hp Lab System, BreathID Smart Systemscore 8.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220494 | BreathID Hp Lab System, BreathID Smart SystemSummary page 4…this 510(k): The purpose of this Special 510(k) submission is to obtain marketing clearance for a modified configuration of the already cleared BreathID® Smart System (K220494). The modified configuration of the cleared BreathID® Smart System supports Windows 10 Operating System while the predicate devic… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All MSQ devicesMSQ Test, Urea (Breath Or Blood): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MSQ
3in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSQ
121in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSQ
1in 2025
MAUDE reports naming product code MSQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 121 | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BreathID Hp Lab System or 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 BreathID Hp Lab System or BreathID Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult…
Read the full statement (132 words)
The BreathID Hp Lab System or 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 BreathID Hp Lab System or BreathID Smart 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 BreathID Hp Lab System consists of the appropriate IDkit Hp kit, and the BreathID Hp device, Auto Sampler and Lab Application. The 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223185: BreathID® Smart System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223185
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026