On-X Life Technologies, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “On-X Life Technologies, Inc.” (first 2014, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 43 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 43 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LWQ | Heart-Valve, Mechanical | 1 | 0 |
| PAW | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement | 1 | 1 |
Review panels
- Cardiovascular (2)
Most recent On-X Life Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141060 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | PAW | 2014-06-06 | 43 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000037 | PMA | ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA | 2001-05-30 |
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2026-02-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named On-X Life Technologies, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT02677974: On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study (Active not recruiting, started 2015-11-10)
- NCT00291525: Randomized On-X Anticoagulation Trial (Completed, started 2006-06-06)
- NCT00639782: Prospective Randomized On-X Versus SJM Evaluation Trial (Completed, started 2003-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under On-X Life Technologies, Inc.?
FDA lists 1 510(k) clearance under the applicant name “On-X Life Technologies, Inc.” (first 2014, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by On-X Life Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name On-X Life Technologies, Inc. is 43 days.
Which FDA product codes appear under On-X Life Technologies, Inc.?
The most frequent FDA product codes under this applicant name are LWQ (Heart-Valve, Mechanical, 1); PAW (Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement, 1).
Next steps
- See all 1 On-X Life Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LWQ, On-X Life Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.