# K041161: Microcyn Wound Care Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences, Inc.
- Decided: May 3, 2005 after 365 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 5 cite it directly.
1 of 42 devices in its family (counting itself) has 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) Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v Sodium Chloride: named in the summary without a submission number

## Most influential descendants
- K070463: Revera Wound Care, Model MDW0060 (2008), 22 descendants of its own
- K093697: Vashe Wound Therapy Solution (2010), 20 descendants of its own
- K092232: Modification to:Vashe Wound Cleansing System, Model 9000-0014 (2009), 16 descendants of its own
- K113693: Nixall TM Wound and Skin Care (2012), 15 descendants of its own
- K133542: Puracyn Plus Skin and Wound (2014), 14 descendants of its own

## Recalls of this device
- Nov 9, 2011 · Not classified · Z-0448-2012: Unapproved drug claims and those not approved under 510K clearance.
- Nov 9, 2011 · Not classified · Z-0450-2012: Unapproved drug claims and those not approved under 510K clearance.

## Indications for use
Dermacyn Wound Dressing is intended for use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.

Source page: https://510kreport.com/device/K041161
Methodology: https://510kreport.com/methodology