# K121227: Manuka Fill

- Pathway: 510(k) (Traditional)
- Applicant: Links Medical Products, Inc.
- Decided: May 23, 2012 after 30 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: 5 generations back to K053095 (2007). 14 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K131796: Manuka Fill Wound Dressing (2014), 3 descendants of its own
- 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

## Indications for use
MANUKA FILL wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA FILL 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, MANUKA FILL 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/K121227
Methodology: https://510kreport.com/methodology