510(k) Report

FDA applicant

On-X Life Technologies, Inc.

Kennesaw2 decisions2001–20145 recalls

FDA records 2 decisions for On-X Life Technologies, Inc. (Kennesaw) from 2001 to 2014: 1 510(k) clearance and 1 original PMA approval. Most are in product codes LWQ (Heart-Valve, Mechanical) and PAW (Nonabsorbable Expanded Polytetrafluoroethylene…). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided On-X Life Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2014: 12015: 12016: 12019: 12026 (partial year): 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — On-X Life Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LWQHeart-Valve, Mechanical1decision
  • PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae…1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141060Chord-X Pre-Measured Loops for Mitral Chordal ReplacementOn-X Life Technologies, Inc. · 20141cites it

What has FDA decided for it lately?

  • K141060Chord-X Pre-Measured Loops for Mitral Chordal ReplacementOn-X Life Technologies, Inc. · 20141 recall
  • P000037ON-X (R) Prosthetic Heart Valve, Model OnxaOn-X Life Technologies, Inc. · 20014 recalls

All 2 as On-X Life Technologies, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • P000037On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33Feb 1, 2026Class II
  • P000037On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic…Jan 17, 2019Class II
  • K141060Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal…Dec 13, 2016Class II
  • P000037On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased…Jun 12, 2015Class II
  • P000037On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the…Feb 12, 2014Class II