# Theo Manufacturing BV

- Location (FDA's records): Bailey, CO
- FDA decisions: 2 (2007–2015): 2 510(k) clearances
- Product codes: FRO (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Southwest Technologies, Inc.: 1 (https://510kreport.com/company/southwest-technologies)
- Derma Sciences, Inc.: 1 (https://510kreport.com/company/derma-sciences)

## Firms that cite its devices most
- Derma Sciences, Inc.: 1 (https://510kreport.com/company/derma-sciences)

## Its most-cited devices
- K053613: L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active (2007), cited by 2

## Recent decisions
- K150676: L-Mesitran Dressing Family II- Soft and Tulle (Dec 23, 2015)
- K053613: L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active (Jul 25, 2007)

Source page: https://510kreport.com/company/theo-manufacturing