# K063517: Healadex-P

- Pathway: 510(k) (Traditional)
- Applicant: Healagenics, Inc.
- Decided: Feb 16, 2007 after 87 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: 3 generations back to K973688 (1997). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983362: NU-Gel * Wound Dressing, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K022995: Collatek Hydrogel, Biocore Medical Technologies, Inc. (2002) Summary page 2.
- K991202: Modification to Woun'dres, Coloplast Corp. (1999) Summary page 2.
- (no number) Gelita-spon Absorbable Gelatin sponge: named in the summary without a submission number

## Most influential descendants
- K221218: Silverlon Wound Contact, Burn Contact Dressings (2022), 1 descendant of its own
- K241225: Silverlon® Wound Contact, Burn Contact Dressing (2024), 0 descendants of its own
- K080471: Radio Bioaquacare (2008), 0 descendants of its own

## Indications for use
HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as: First and second degree burns Severe sunburns Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears HEALADEX-P dressing should be used under health care professional direction for the following indications: Pressure ulcers, Stage I-JV Lower extremity ulcers Venous ulcers Arterial ulcers Ulcers of mixed etiology Diabetic ulcers Donor sites and skin grafts Burns caused by radiation oncology procedures

Source page: https://510kreport.com/device/K063517
Methodology: https://510kreport.com/methodology