510(k) · Cleared
ClearedValidation of the Breathid System, for the Detection of Helicbactor Pylori
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oridion Medical 1987, Ltd. · MSQ Test, Urea (Breath Or Blood)
Cleared on Jul 9, 2001 as substantially equivalent to K972352 (Meretek Diagnostics, Inc., 1997) and 1 other predicate after a 53-day review. Its family tree reaches back 2 generations to 1996. 8 later devices descend from it.
- Decided
- Jul 9, 2001
- Review
- 53 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952220 (1996). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK952220 Meretek Breath Test for H.Pylori Collection KitMeretek Diagnostics, Inc. · 1996
- 1 generation backK972352 The Meretek Ubt Breath Test for H.PyloriMeretek Diagnostics, Inc. · 1997
- This deviceK011668 Validation of the Breathid System, for the Detection of Helicbactor…Oridion Medical 1987, Ltd. · 2001
- Descendant · cites it directly · 7 of its ownK130524 Breathid HP SystemExalenz Bioscience, Ltd. · 2013
- Descendant · 2 generations on · 4 of its ownK162150 BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2016
- Descendant · 3 generations on · 3 of its ownK173777 BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2018
- Descendant · 4 generations on · 2 of its ownK193610 BreathID Smart SystemExalenz Bioscience, Ltd. · 2020
- Descendant · 4 generations on · 1 of its ownK220494 BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130524Breathid HP SystemExalenz Bioscience, Ltd. · 2013 · cites it directly7descendants
- K162150BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2016 · 2 generations on4descendants
- K173777BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2018 · 3 generations on3descendants
- K193610BreathID Smart SystemExalenz Bioscience, Ltd. · 2020 · 4 generations on2descendants
- K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952220 | Meretek Breath Test for H.Pylori Collection Kit | Meretek Diagnostics, Inc. | 1996 | — |
| −1 | K972352 | The Meretek Ubt Breath Test for H.Pylori | Meretek Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K011668 | Validation of the Breathid System, for the Detection of Helicbactor Pylori | Oridion Medical 1987, Ltd. | 2001 | — |
| +1 | K130524 | Breathid HP System | Exalenz Bioscience, Ltd. | 2013 | — |
| +2 | K162150 | BreathID Hp Lab System | Exalenz Bioscience, Ltd. | 2016 | — |
| +3 | K173777 | BreathID Hp Lab System | Exalenz Bioscience, Ltd. | 2018 | — |
| +4 | K193610 | BreathID Smart System | Exalenz Bioscience, Ltd. | 2020 | — |
| +4 | K220494 | BreathID Hp Lab System, BreathID Smart System | Meridian Bioscience Israel, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K972352 | The Meretek Ubt Breath Test for H.PyloriSummary page 4…t’s condition. The system is for use by trained operators under the supervision of physicians, nurses or other healthcare professionals. . The Meretek UBT® Breath test (K972352) The intended use of the Meretek test is for use in the qualitative detection of urease associated with Helicobacter pylori in t… | 1997 |
| * | K952220 | Meretek Breath Test for H.Pylori Collection KitSummary page 4…initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. This test is essentially equivalent to the test described in Meretek K952220 except that the intended use labeling has been expanded to include post-treatment monitoring of Helicobacter pylori. ¢ Intended… | 1996 |
| * | — | CLOtest® Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130524 | Breathid HP System | 2013 | 7 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130524 (Exalenz Bioscience, Ltd., 2013) has gone furthest, with 7 descendants of its own.
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.
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™ 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011668: Validation of the Breathid System, for the Detection of Helicbactor Pylori.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011668
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026