# K971126: Hydrocolloid Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies, Ltd.
- Decided: Jun 24, 1997 after 89 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
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Duoderm CGF / Extra Thin Hydrocolloid Dressings: named in the summary without a submission number

## Most influential descendants
- K973855: IT Hydrocolloid with Zinc (1997), 5 descendants of its own
- K060237: CMB Antimicrobial Dressing (2006), 4 descendants of its own
- K081977: Prosit Wound Treatment Device (2008), 3 descendants of its own
- K983303: Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound Dressings (1998), 3 descendants of its own
- K130350: Procellera (2013), 2 descendants of its own

## Indications for use
Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressings may be used for the management of wounds including: Partial - full thickness wounds, i.e. arterial/venous, diabetic ulcers Post-operative surgical wounds Donor Sites Trauma Wounds Dermal Lesions Protective dressing

Source page: https://510kreport.com/device/K971126
Methodology: https://510kreport.com/methodology