510(k) Report

FDA applicant

Virchow Biotech Pvt, Ltd.

Portland, OR3 decisions2014–20180 recalls

FDA records 3 decisions for Virchow Biotech Pvt, Ltd. (Portland, OR) from 2014 to 2018: 3 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 3 predicates, 0 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 Virchow Biotech Pvt, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014: 12016: 12018: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Virchow Biotech Pvt, Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K132326Ionsil GelVirchow Biotech Pvt, Ltd. · 20141cites it

What has FDA decided for it lately?

  • K172747Hyaluronic Acid Topical Wound CreamVirchow Biotech Pvt, Ltd. · 2018
  • K153565Donasorb Silver Wound DressingVirchow Biotech Pvt, Ltd. · 2016
  • K132326Ionsil GelVirchow Biotech Pvt, Ltd. · 2014

All 3 as Virchow Biotech Pvt, Ltd. →