510(k) Report

FDA applicant

North America BioPharma

Erie, CO2 decisions2004–20140 recalls

FDA records 2 decisions for North America BioPharma (Erie, CO) from 2004 to 2014: 2 510(k) clearances. All are in product code NRN (Leeches, Medicinal). Its devices cite 1 predicate, 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

How often FDA has decided North America BioPharma’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • NRNLeeches, Medicinal2decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K040187Medicinal LeechesNorth America BioPharma · 20042cite it
  • K132958Medicinal LeechesNorth America BioPharma · 20141cites it

What has FDA decided for it lately?

  • K132958Medicinal LeechesNorth America BioPharma · 2014
  • K040187Medicinal LeechesNorth America BioPharma · 2004

All 2 as North America BioPharma →