510(k) Report

FDA applicant

Maduro Medical, Inc.

Campbell, CA4 decisions2023–20260 recalls

FDA records 4 decisions for Maduro Medical, Inc. (Campbell, CA) from 2023 to 2026: 4 510(k) clearances. Most are in product codes QJP (Catheter, Percutaneous, Neurovasculature) and NRY (Catheter, Thrombus Retriever). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 144 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2023: 12025: 12026 (partial year): 2
2023high 2 (2026) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Maduro Medical, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Maduro Medical, Inc.’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?

  • QJPCatheter, Percutaneous, Neurovasculature3decisions
  • NRYCatheter, Thrombus Retriever1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 143 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 144 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc. · 20232cite it

What has FDA decided for it lately?

  • K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc. · 2026
  • K253975Radical 6F Access CatheterMaduro Medical, Inc. · 2026
  • K243577Radical the Dude 8F Guide CatheterMaduro Medical, Inc. · 2025
  • K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc. · 2023

All 4 as Maduro Medical, Inc. →