# K033453: Kendall Ultec Pro AG+ Hydrocolloid Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare
- Decided: Apr 29, 2004 after 182 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 K970566 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943636: Curaderm Alginate Hydrocolloid, Kendall Healthcare Products Co. Div.Of Tyco Health (1994) Summary page 1.
- K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing, Maersk Medical, Ltd. (1999) Summary page 1.
- K013525: Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM), Coloplast Corp. (2002)

## Indications for use
The Ultec Pro Ag+ Hydrocolloid Dressings are indicated for use on venous stasis ulcers, pressure ulcers, arterial ulcers, diabetic ulcers, donor sites, lacerations, post surgical incisions, and other dry to lightly exudating symptoms.

Source page: https://510kreport.com/device/K033453
Methodology: https://510kreport.com/methodology