510(k) Report

FDA applicant

Potrero Medical, Inc.

Hayward, CA2 decisions2016–20230 recalls

FDA records 2 decisions for Potrero Medical, Inc. (Hayward, CA) from 2016 to 2023: 2 510(k) clearances. All are in product code EZL (Catheter, Retention Type, Balloon). Its devices cite 3 predicates, 1 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 Potrero Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016: 12023: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Potrero Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Potrero 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?

  • EZLCatheter, Retention Type, Balloon2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K153655Accuryn Monitoring SystemPotrero Medical, Inc. · 20162cite it

What has FDA decided for it lately?

  • K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp…Potrero Medical, Inc. · 2023
  • K153655Accuryn Monitoring SystemPotrero Medical, Inc. · 2016

All 2 as Potrero Medical, Inc. →