510(k) · Cleared
ClearedBreathid HP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exalenz Bioscience, Ltd. · MSQ Test, Urea (Breath Or Blood)
Cleared on May 22, 2013 as substantially equivalent to K011668 (Oridion Medical 1987, Ltd., 2001) after an 83-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it.
- Decided
- May 22, 2013
- Review
- 83 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952220 (1996). 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK952220 Meretek Breath Test for H.Pylori Collection KitMeretek Diagnostics, Inc. · 1996
- 2 generations backK972352 The Meretek Ubt Breath Test for H.PyloriMeretek Diagnostics, Inc. · 1997
- 1 generation backK011668 Validation of the Breathid System, for the Detection of Helicbactor…Oridion Medical 1987, Ltd. · 2001
- This deviceK130524 Breathid HP SystemExalenz Bioscience, Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK162150 BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2016
- Descendant · 2 generations on · 3 of its ownK173777 BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK193610 BreathID Smart SystemExalenz Bioscience, Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK220494 BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK173772 BreathID Hp SystemExalenz Bioscience, Ltd. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K162150BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2016 · cites it directly4descendants
- K173777BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2018 · 2 generations on3descendants
- K193610BreathID Smart SystemExalenz Bioscience, Ltd. · 2020 · 3 generations on2descendants
- K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd. · 2022 · 3 generations on1descendant
- K173772BreathID Hp SystemExalenz Bioscience, Ltd. · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952220 | Meretek Breath Test for H.Pylori Collection Kit | Meretek Diagnostics, Inc. | 1996 | — |
| −2 | K972352 | The Meretek Ubt Breath Test for H.Pylori | Meretek Diagnostics, Inc. | 1997 | — |
| −1 | K011668 | Validation of the Breathid System, for the Detection of Helicbactor Pylori | Oridion Medical 1987, Ltd. | 2001 | — |
| 0 (this device) | K130524 | Breathid HP System | Exalenz Bioscience, Ltd. | 2013 | — |
| +1 | K162150 | BreathID Hp Lab System | Exalenz Bioscience, Ltd. | 2016 | — |
| +2 | K173777 | BreathID Hp Lab System | Exalenz Bioscience, Ltd. | 2018 | — |
| +3 | K193610 | BreathID Smart System | Exalenz Bioscience, Ltd. | 2020 | — |
| +3 | K220494 | BreathID Hp Lab System, BreathID Smart System | Meridian Bioscience Israel, Ltd. | 2022 | — |
| +1 | K173772 | BreathID Hp System | Exalenz Bioscience, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K011668 | Validation of the Breathid System, for the Detection of Helicbactor PyloriSummary page 1…ied BreathlD® Hp System is claimed to be substantially equivalent to the following legally marketed predicate device: BreathlD® System, Exalenz Bioscience Ltd., K01 1668 General Description: The modified BreathlD®D Hp System is a non-invasive breath test system for detecting the presence of Helico… | 2001 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162150 (Exalenz Bioscience, Ltd., 2016) has gone furthest, with 4 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. 2013, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130524 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130524: Breathid HP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130524
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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