510(k) · Cleared
ClearedPylo-Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arj Medical, Inc. · LYR Helicobacter Pylori
Cleared on May 1, 2006 after a 214-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 1, 2006
- Review
- 214 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK052708 Pylo-PlusArj Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK101234 Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary…Ventana Medical Systems, Inc. · 2011 · Recalled (Class I)
Class I recalls in this family
- K101234 Ventana Anti-Helicobacter Pylori (SP48) Rabbit…cites it directly · 2011
Most influential descendants
Showing 1 of 1 · See all- K101234Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052708 | Pylo-Plus | Arj Medical, Inc. | 2006 | — |
| +1 | K101234 | Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101234 | Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody Class I | 2011 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K101234Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K101234 (Ventana Medical Systems, Inc., 2011) has gone furthest, with 0 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 | — |
What is it indicated for?
Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens for the presumptive determination of Helicobacter pyloni in symptomatic patients.
ARJI Medical's Pylo-Plus Rapid Urease Tests are for single use by medical and laboratory personnel. Pylo-Plus is intended for use in screening at-risk patients to assist diagnosis in the field of Gastroenterology.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052708: Pylo-Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052708
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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