510(k) · Cleared
ClearedThe Meretek Ubt Breath Test for H.Pylori
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meretek Diagnostics, Inc. · MSQ Test, Urea (Breath Or Blood)
Cleared on Oct 29, 1997 as substantially equivalent to K952220 (Meretek Diagnostics, Inc., 1996) after a 127-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Oct 29, 1997
- Review
- 127 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952220 (1996). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952220 Meretek Breath Test for H.Pylori Collection KitMeretek Diagnostics, Inc. · 1996
- This deviceK972352 The Meretek Ubt Breath Test for H.PyloriMeretek Diagnostics, Inc. · 1997
- Descendant · cites it directly · 8 of its ownK011668 Validation of the Breathid System, for the Detection of Helicbactor…Oridion Medical 1987, Ltd. · 2001
- Descendant · 2 generations on · 7 of its ownK130524 Breathid HP SystemExalenz Bioscience, Ltd. · 2013
- Descendant · 3 generations on · 4 of its ownK162150 BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2016
- Descendant · 4 generations on · 3 of its ownK173777 BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2018
- Descendant · 5 generations on · 2 of its ownK193610 BreathID Smart SystemExalenz Bioscience, Ltd. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K011668Validation of the Breathid System, for the Detection of Helicbactor PyloriOridion Medical 1987, Ltd. · 2001 · cites it directly8descendants
- K130524Breathid HP SystemExalenz Bioscience, Ltd. · 2013 · 2 generations on7descendants
- K162150BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2016 · 3 generations on4descendants
- K173777BreathID Hp Lab SystemExalenz Bioscience, Ltd. · 2018 · 4 generations on3descendants
- K193610BreathID Smart SystemExalenz Bioscience, Ltd. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952220 | Meretek Breath Test for H.Pylori Collection Kit | Meretek Diagnostics, Inc. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K130524 | Breathid HP System | Exalenz Bioscience, Ltd. | 2013 | — |
| +3 | K162150 | BreathID Hp Lab System | Exalenz Bioscience, Ltd. | 2016 | — |
| +4 | K173777 | BreathID Hp Lab System | Exalenz Bioscience, Ltd. | 2018 | — |
| +5 | K193610 | BreathID Smart System | Exalenz Bioscience, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K952220 | Meretek Breath Test for H.Pylori Collection KitSummary page 1…was officially renamed Helicobacter pylori in 1989. Class: I The Predicate Device Since this Premarket Notification is for labeling modification to a cleared device (K952220), the predicate device is the device itself: The MERETEK UBT® Breath Test for Detection of H. pylori. Description of the Device… | 1996 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011668 | Validation of the Breathid System, for the Detection of Helicbactor Pylori | 2001 | 8 |
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?
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 MERETEK UBT™ Breath Test Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. For this purpose, the system utilizes a Gas Isotope Ratio Mass Spectrometer ("GIRMS") for the measurement of the ratio of 13CO, to *CO, in breath samples.
For administrationn by health care professionals. To be administered under a physician’s supervision.
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/K972352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972352: The Meretek Ubt Breath Test for H.Pylori.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972352
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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