# K053613: L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active

- Pathway: 510(k) (Traditional)
- Applicant: Theo Manufacturing BV
- Decided: Jul 25, 2007 after 575 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K872165 (1987). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872165: Elasto-Gel Occlusive Dressing, Southwest Technologies, Inc. (1987) Summary page 1.

## Most influential descendants
- K110546: Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey (2011), 1 descendant of its own
- K222143: Apis (R), Veris (TM) (2023), 0 descendants of its own
- K150676: L-Mesitran Dressing Family II- Soft and Tulle (2015), 0 descendants of its own

## Indications for use
L-Mesitran Hydro and L-Mesitran Border L-Mesitran Hydro and Border dressings are indicated for acute and chronic superficial wounds such as: bruises, cuts, bedsores, first and second-degree burns and other traumatic wounds, venous and arterial ulcera, diabetes ulcers, donor sites, and post-operative wounds. L-Mesitran Hydro and Border should not be used as a covering for deep narrow cavities, dirty wounds (these should first be cleansed), third-degree burns and fistulae. L-Mesitran Net L-Mesitran Net Dressings are indicated for acute and chronic superficial wounds such as: bruises, skin tears, pressure ulcers, venous and arterial ulcera, diabetes ulcers, donor sites, cuts, first and second degree burns, postoperative wounds and other external wounds caused by trauma. L-Mesitran Net is to be used in conjunction with other secondary dressings. It should not be used on its own as a covering for dirty, infected and heavily exudating wounds (should first be cleansed), third degree burns, or deep narrow cavities. L-Mesitran Active L-Mesitran Active Dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds.

Source page: https://510kreport.com/device/K053613
Methodology: https://510kreport.com/methodology