510(k) Report

FDA applicant

Wellspect Healthcare

San Diego, CA1 decision2013–20130 recalls

FDA records 1 decision for Wellspect Healthcare (San Diego, CA) in 2013: 1 510(k) clearance. All are in product code EZD (Catheter, Straight). 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 Wellspect Healthcare’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Wellspect Healthcare by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • EZDCatheter, Straight1decision

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.

  • K123751Lofric SenseWellspect Healthcare · 20131cites it

What has FDA decided for it lately?

  • K123751Lofric SenseWellspect Healthcare · 2013

The one decision as Wellspect Healthcare →

Other applicant names beginning “Wellspect”

FDA records each applicant name separately; these may or may not be the same firm.

Wellspect AB 3