510(k) Report

FDA applicant

Pluromed, Inc.

Woburn, MA4 decisions2009–20110 recalls

FDA records 4 decisions for Pluromed, Inc. (Woburn, MA) from 2009 to 2011: 4 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and ONJ (Dissolvable Gel For Preventing Ureteral Stone…). Its devices cite 7 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

2in 2011

2009: 22011: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Pluromed, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pluromed, 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?

  • KODCatheter, Urological3decisions
  • ONJDissolvable Gel For Preventing Ureteral Stone Migration1decision

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K103349Backstop CatheterPluromed, Inc. · 20111cites it
  • K110491Backstop CatheterPluromed, Inc. · 20111cites it
  • K090270Backstop Catheter, Model 60-0000-3100Pluromed, Inc. · 20091cites it

What has FDA decided for it lately?

  • K110491Backstop CatheterPluromed, Inc. · 2011
  • K103349Backstop CatheterPluromed, Inc. · 2011
  • K090430Backstop and Backstop InjectorPluromed, Inc. · 2009
  • K090270Backstop Catheter, Model 60-0000-3100Pluromed, Inc. · 2009

All 4 as Pluromed, Inc. →