FDA applicant

Cure Medical, LLC

Laguna Niguel, CA4 decisions2007–20132 recalls

FDA records 4 decisions for Cure Medical, LLC (Laguna Niguel, CA) from 2007 to 2013: 4 510(k) clearances. Most are in product codes EZD (Catheter, Straight) and KOD (Catheter, Urological). Its devices cite 6 predicates, 4 of them its own earlier devices. 2 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, gastroenterology and urology panel, where it files most

How often FDA has decided Cure Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cure Medical, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cure Medical, LLC’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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Other applicant names beginning “Cure”

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

Cure Point Therapeutics, Inc. 1

Cure Medical, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Cure”