PMA · Approved
Recalled · Class II · 2026ON-X (R) Prosthetic Heart Valve, Model Onxa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
On-X Life Technologies, Inc. · LWQ Heart-Valve, Mechanical
Approved on May 30, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 271-day review. It has been recalled 4 times.
- Decided
- May 30, 2001
- Review
- 271 days
- Class
- Class III
- Product code
- LWQ
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P000037 has 65 supplements since 2002: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2002 | 2 |
| 2003 | 1 |
| 2005 | 4 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 6 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 6 |
| 2016 | 4 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 5 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2026 | Class II | Z-2133-2026 | Under Investigation by firm | Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. |
| Jan 17, 2019 | Class II | Z-1073-2019 | Employee error | On-X Valve was mislabeled with the incorrect serial number. |
| Jun 12, 2015 | Class II | Z-2715-2017 | Labeling mix-ups | Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring. |
| Feb 12, 2014 | Class II | Z-3108-2017 | Other | Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWQ devicesLWQ Heart-Valve, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWQ
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWQ
Too few LWQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWQ
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWQ
330in 2025
MAUDE reports naming product code LWQ, 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 | 12 | — | 0 | 88 |
| 2008 | 15 | — | 0 | 90 |
| 2009 | 8 | — | 0 | 91 |
| 2010 | 6 | — | 0 | 119 |
| 2011 | 16 | — | 0 | 139 |
| 2012 | 21 | — | 0 | 122 |
| 2013 | 17 | — | 0 | 134 |
| 2014 | 11 | — | 0 | 134 |
| 2015 | 14 | — | 0 | 139 |
| 2016 | 13 | — | 0 | 202 |
| 2017 | 11 | — | 0 | 299 |
| 2018 | 8 | — | 0 | 434 |
| 2019 | 4 | — | 0 | 350 |
| 2020 | 6 | — | 0 | 372 |
| 2021 | 9 | — | 0 | 287 |
| 2022 | 8 | — | 0 | 297 |
| 2023 | 9 | — | 0 | 455 |
| 2024 | 6 | — | 0 | 404 |
| 2025 | 9 | — | 0 | 330 |
| 2026 | 5 | — | 1 | — |
https://510kreport.com/device/P000037 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000037: ON-X (R) Prosthetic Heart Valve, Model Onxa.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000037
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026