# K131796: Manuka Fill Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Links Medical Products, Inc.
- Decided: Mar 14, 2014 after 269 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K053095 (2007). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121227: Manuka Fill, Links Medical Products, Inc. (2012) Summary page 2.
- 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.

## Most influential descendants
- K173911: Medline Burn and Wound Dressing (2018), 2 descendants of its own
- K254191: IWD-Gel™ (2026), 0 descendants of its own
- K190224: Medline Burn and Wound Dressing (OTC) (2019), 0 descendants of its own

## Recalls of this device
- May 3, 2023 · Class II · Z-1982-2023: Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137

## Indications for use
MANUKA FILL wound dressing may be used Over-The-Counter for the management of: > Minor Abrasions > Minor Lacerations > Minor Cuts > Minor Scalds and Minor Bums MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue. Under the supervision of a bealthicare professional, MANUKA FILL wound dressing is indicated for the management of: > Leg Ulcers > Pressure Ulcers > I"1 and 2 nd Degree Bums > Diabetic Foot Ulcers > Surgical Wounds > Trauma Wounds MANlJKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.

Source page: https://510kreport.com/device/K131796
Methodology: https://510kreport.com/methodology