510(k) Report

FDA applicant

Theo Manufacturing BV

Bailey, CO2 decisions2007–20150 recalls

FDA records 2 decisions for Theo Manufacturing BV (Bailey, CO) from 2007 to 2015: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). 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

How often FDA has decided Theo Manufacturing BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Theo Manufacturing BV 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?

  • FRODressing, Wound, Drug2decisions

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.

  • K053613L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran ActiveTheo Manufacturing BV · 20072cite it

What has FDA decided for it lately?

  • K150676L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV · 2015
  • K053613L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran ActiveTheo Manufacturing BV · 2007

All 2 as Theo Manufacturing BV →