# K110042: Manukatex

- Pathway: 510(k) (Traditional)
- Applicant: Manuka Medical Limited
- Decided: Mar 24, 2011 after 77 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: 6 generations back to K053095 (2007). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102659: Manukahd, Manukahd Rope, Manukahd Border, Manuka Medical Limited (2010) Summary page 1.
- K092689: Manukapli Wound Dressing, Manuka Medical Limited (2010) Summary page 1.

## Most influential descendants
- K120976: Manuka IG (2012), 1 descendant of its own
- K133934: Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with Silicone Adhesive Border) (2014), 0 descendants of its own

## Indications for use
MANUKAtex wound dressings are sterile, single-use wound care dressings for use in moist wound management. MANUKAtex wound dressings may be used Over-The-Counter for: > Minor Abrasions > Lacerations > Minor Cuts > Minor Scalds and Burns Under the supervision of a healthcare professional, MANUKAtex wound dressings may be used for: > Leg Ulcers > Pressure Ulcers > 1st and 2nd Degree Burns (superficial and Partial Thickness) > Diabetic Foot Ulcers > Surgical Wounds > Traumatic Wounds

Source page: https://510kreport.com/device/K110042
Methodology: https://510kreport.com/methodology