# K053538: Modification to Phytacare Alginate Hydrogel Wound Filler

- Pathway: 510(k) (Traditional)
- Applicant: Curapharm, Inc.
- Decided: Oct 10, 2006 after 294 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 K935096 (1994). 4 ancestors in all.
15 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)
- K962218: Carrasyn Hydrogel Wound Dressing,Carragauze Pads,Carragauze Strips,Carrasorb M FDG, Carrington Laboratories, Inc. (1996) Summary page 1.
- K935096: Biolex Impregnated Wound Dressing, C.R. Bard, Inc. (1994) Summary page 1.
- K954738: Dermagran Hydrophilic Wound Dressing, Derma Sciences, Inc. (1995) Summary page 1.
- K942270: Saf-Gel Hydrating Dermal Wound Dressing, Calgon Vestal Div. (1994) Summary page 1.
- (no number) TransiGel® Conformable Gel Dressing: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K053450: Atlantis Abutment for Zimmer Interface, Atlantis Components, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey (2008), 14 descendants of its own
- K092689: Manukapli Wound Dressing (2010), 10 descendants of its own
- K121227: Manuka Fill (2012), 4 descendants of its own
- K131796: Manuka Fill Wound Dressing (2014), 3 descendants of its own
- K102659: Manukahd, Manukahd Rope, Manukahd Border (2010), 3 descendants of its own

## Indications for use
The Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of 1st and 2 nd degree burns, minor cuts and abrasions. Under the care of a healthcare professional the Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of diabetic ulcers, foot ulcers, 1st and 2 nd degree burns, pressure ulcers (stages I-IV), cuts and abrasions.

Source page: https://510kreport.com/device/K053538
Methodology: https://510kreport.com/methodology