510(k) Report

FDA applicant

Urodynamix Technologies, Ltd.

Vancouver Bc, CA1 decision2008–20080 recalls

FDA records 1 decision for Urodynamix Technologies, Ltd. (Vancouver Bc, CA) in 2008: 1 510(k) clearance. All are in product code FEN (Device, Cystometric, Hydraulic). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Urodynamix Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Urodynamix Technologies, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Urodynamix Technologies, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FENDevice, Cystometric, Hydraulic1decision

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.

  • K082701Uronirs, Model 2000Urodynamix Technologies, Ltd. · 20081cites it

What has FDA decided for it lately?

  • K082701Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008

The one decision as Urodynamix Technologies, Ltd. →