# K972646: AD-Heal Hydrogel Dressing, Various Sizes

- Pathway: 510(k) (Traditional)
- Applicant: Ludlow Technical Products
- Decided: Aug 21, 1997 after 37 days
- Product code: NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic)
- Device class: 1
- Regulation: 21 CFR 878.4022
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. Ad-Heal™ Hydrogel Dressing is indicated for: Partial Thickness Wounds First and Second Degree Burns Pressure Ulcers Donor Sites Abrasions Note: Ad-Heal™ is not indicated for full thickness or infected wounds or for third degree burns. This is a disposable, short term (less than 72 hours between changes) device for single patient use.

Source page: https://510kreport.com/device/K972646
Methodology: https://510kreport.com/methodology