# K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula

- Pathway: 510(k) (Traditional)
- Applicant: Innovacyn, Inc.
- Decided: Nov 19, 2015 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
Longest line of descent: 8 generations back to K914579 (1992). 48 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093585: Microcyn Skin and Wound Hydrogel, Oculus Innovative Sciences, Inc. (2010) Summary page 4.
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 4.
- K141863: Puricore Wound Hydrogel Spray Dressing, Puricore, Inc. (2015). Cleared while this submission was under review Summary page 4.
- K102945: Pediacyn Atopic Dermatitis Hydrogel, Oculus Innovative Sciences, Inc. (2011) Summary page 4.

## Most influential descendants
- K160095: Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (2016), 3 descendants of its own
- K181074: Simple Science Antimicrobial Facial and Eyelid Cleanser (2018), 2 descendants of its own
- K233399: Microdacyn Wound Care Solution (2024), 1 descendant of its own
- K171935: Alevicyn SG Antimicrobial Gel (2017), 1 descendant of its own
- K254041: SkinSmart Antimicrobial HydroGel (2026), 0 descendants of its own

## Indications for use
For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process. For Professional Use: Puracyn® Plus Antimicrobial Hydrogel Professional Formula is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn® Plus Antimicrobial Hydrogel Professional Formula relieves itch and pain associated with dermal irritation, sores, injuries and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. Puracyn® Plus Antimicrobial Hydrogel Professional Formula is indicated for the management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.

Source page: https://510kreport.com/device/K150799
Methodology: https://510kreport.com/methodology