510(k) · Cleared
ClearedMeretek Breath Test for H.Pylori Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meretek Diagnostics, Inc. · LYR Helicobacter Pylori
Cleared on Sep 17, 1996 after a 495-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Sep 17, 1996
- Review
- 495 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK952220 Meretek Breath Test for H.Pylori Collection KitMeretek Diagnostics, Inc. · 1996
- Descendant · cites it directly · 9 of its ownK972352 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K972352The Meretek Ubt Breath Test for H.PyloriMeretek Diagnostics, Inc. · 1997 · cites it directly9descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYR? 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 LYR device
- #1 K232892 Hp Detect™ Stool Antigen ELISAscore 7.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 113 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?
- Of its descendants, K972352 (Meretek Diagnostics, Inc., 1997) has gone furthest, with 9 descendants of its own.
How does its category compare?
All LYR devicesLYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYR
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LYR
86in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYR
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYR
2in 2023
MAUDE reports naming product code LYR, 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 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 4 | 86 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 2 | — | 1 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952220: Meretek Breath Test for H.Pylori Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952220
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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