# K020041: Ialuset Hydrocolloid

- Pathway: 510(k) (Traditional)
- Applicant: Institut Biochimique SA (Ibsa)
- Decided: Mar 14, 2002 after 66 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 K881050 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881050: Duoderm (R) CGF, Convatec, A Division of E.R. Squibb & Sons (1988) Summary page 1.
- K971126: Hydrocolloid Wound Dressings, Innovative Technologies, Ltd. (1997) Summary page 1.

## Indications for use
For over-the-counter use, IALUSET HYDROCOLLOID may be applied to: abrasions lacerations minor cuts minor scalds minor burns Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to: leg ulcers (venous stasis ulcers, arterial ulcers) diabetic ulcers pressure ulcers (stage I - IV) surgical wounds (postoperative, dermatological excisions, donor sites) burns (first and second degree only) traumatic wounds

Source page: https://510kreport.com/device/K020041
Methodology: https://510kreport.com/methodology