# P000037: ON-X (R) Prosthetic Heart Valve, Model Onxa

- Pathway: PMA
- Applicant: On-X Life Technologies, Inc.
- Decided: May 30, 2001 after 271 days
- Product code: LWQ (Heart-Valve, Mechanical)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 1, 2026 · Class II · Z-2133-2026: 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: On-X Valve was mislabeled with the incorrect serial number.
- Jun 12, 2015 · Class II · Z-2715-2017: 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: Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.

Source page: https://510kreport.com/device/P000037
Methodology: https://510kreport.com/methodology