510(k) · Cleared
ClearedFlexsure HP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smithkline Diagnostics, Inc. · LYR Helicobacter Pylori
Cleared on May 18, 1994 after a 218-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 18, 1994
- Review
- 218 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK934863 Flexsure HPSmithkline Diagnostics, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK024350 Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test DeviceACON Laboratories, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK151935 Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H.…Alere San Diego, Incorporated · 2015
- Descendant · cites it directly · 0 of its ownK960183 Flexsure HP,Controls for Flexsurehp,Flexpack HP (Abbott…Smithkline Diagnostics, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K024350Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test DeviceACON Laboratories, Inc. · 2003 · cites it directly1descendant
- K151935Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood…Alere San Diego, Incorporated · 2015 · 2 generations on0descendants
- K960183Flexsure HP,Controls for Flexsurehp,Flexpack HP (Abbott Diagnostics)Andcontrols for…Smithkline Diagnostics, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934863 | Flexsure HP | Smithkline Diagnostics, Inc. | 1994 | — |
| +1 | K024350 | Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device | ACON Laboratories, Inc. | 2003 | — |
| +2 | K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori… | Alere San Diego, Incorporated | 2015 | — |
| +1 | K960183 | Flexsure HP,Controls for Flexsurehp,Flexpack HP (Abbott… | Smithkline Diagnostics, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K024350 (ACON Laboratories, Inc., 2003) has gone furthest, with 1 descendant 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/K934863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934863: Flexsure HP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934863
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026