# K133934: Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with Silicone Adhesive Border)

- Pathway: 510(k) (Traditional)
- Applicant: Links Medical Products, Inc.
- Decided: May 2, 2014 after 130 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: 8 generations back to K053095 (2007). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120976: Manuka IG, Links Medical Products, Inc. (2012) Summary page 1.
- K072068: Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in Plastic Bag Containers, Bioartificial Gel Technologies (Bagtech), Inc. (2007) Summary page 1.

## Indications for use
MANUKA FOAM HG wound dressings are sterile, single-use wound care dressings for use in moist wound management of: > Leg Ulcers > Pressure Ulcers > 1st and 2nd Degree Burns > Diabetic Foot Ulcers > Surgical Wounds > Trauma Wounds A moist wound environment allows autolytic debridement of necrotic tissue.

Source page: https://510kreport.com/device/K133934
Methodology: https://510kreport.com/methodology