# K973855: IT Hydrocolloid with Zinc

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies, Ltd.
- Decided: Dec 1, 1997 after 53 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 K951499 (1995). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951499: Dermagran Hydrophilic Ointment, Derma Sciences, Inc. (1995) Summary page 1.
- K971126: Hydrocolloid Wound Dressings, Innovative Technologies, Ltd. (1997) Summary page 1.

## Most influential descendants
- K060237: CMB Antimicrobial Dressing (2006), 4 descendants of its own
- K081977: Prosit Wound Treatment Device (2008), 3 descendants of its own
- K130350: Procellera (2013), 2 descendants of its own
- K160783: Procellera (2016), 1 descendant of its own
- K180533: Procellera Composite Antibacterial Wound Dressing (2018), 0 descendants of its own

## Indications for use
Innovative Technologies' Hydrocolloid with Zinc Wound Dressings may be used for the management of wounds including: Partial - full thickness wounds, ie. arterial, venous, diabetic ulcers Post-operative surgical wounds Superficial burns (1st & 2nd degree) Donor Sites Trauma Wounds Dermal Lesions Protective dressing

Source page: https://510kreport.com/device/K973855
Methodology: https://510kreport.com/methodology