# K022584: Cardiotech Antibotic Hydrogel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Cardiotech Intl.
- Decided: Dec 30, 2002 after 147 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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 K943314 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943314: Adhesive Bandages with Otc Drug, Johnson & Johnson Consumer Products, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K830457: Pacing Lead #Pma F 860, Ela Medical, Inc. (1983). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K053476: Allwound (2006), 1 descendant of its own
- K211943: Microlyte Ag/Lidocaine (2024), 0 descendants of its own

## Indications for use
CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and full-thickness wounds. They may be used on the following wounds: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and lacerations Donor sites

Source page: https://510kreport.com/device/K022584
Methodology: https://510kreport.com/methodology