# K101118: Activon Tulle

- Pathway: 510(k) (Traditional)
- Applicant: Calidad Solutions, Inc.
- Decided: Dec 15, 2010 after 238 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey, Derma Sciences, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
OTC: For minor wounds, ulcerations and burns, abraded skin, and irritated areas. Professional: Intended in the management of: * diabetic foot ulcers; * leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); * pressure ulcers/sores (partial and fuill thickness); * 1st and 2nd degree partial thickness bums; * grafted and donor sites and traumatic and surgical wounds.

Source page: https://510kreport.com/device/K101118
Methodology: https://510kreport.com/methodology