# K093585: Microcyn Skin and Wound Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences, Inc.
- Decided: Mar 8, 2010 after 109 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K830708 (1983). 12 ancestors in all.
25 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090092: Sockit! and Mcmerlin Dermal Wound Gel, Mcmerlin Dental Products LP (2009) Summary page 1.
- K090725: Oculus Microcyn Wound Gel, Oculus Innovative Sciences, Inc. (2009) Summary page 1.

## Most influential descendants
- K102945: Pediacyn Atopic Dermatitis Hydrogel (2011), 17 descendants of its own
- K123071: Vashe Skin and Wound Hydrogel (2013), 11 descendants of its own
- K141863: Puricore Wound Hydrogel Spray Dressing (2015), 10 descendants of its own
- K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula (2015), 9 descendants of its own
- K153648: Microcyn Plus Skin and Wound Hydrogel (2016), 6 descendants of its own

## Recalls of this device
- Nov 9, 2011 · Not classified · Z-0451-2012: Unapproved drug claims and those not approved under 510K clearance.

## Indications for use
OTC: Microcyn Skin and Wound HydroGel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Microcyn is also indicated for the management of irritation and pain from minor sunburn. Professional Use: Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microcyn Skin and Wound HydroGel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.

Source page: https://510kreport.com/device/K093585
Methodology: https://510kreport.com/methodology