# K141863: Puricore Wound Hydrogel Spray Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Puricore, Inc.
- Decided: May 14, 2015 after 308 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: 7 generations back to K914579 (1992). 47 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K123071: Vashe Skin and Wound Hydrogel, Puricore, Inc. (2013) Summary page 4.
- K101882: Prontosan Antimicrobial Wound Gel, B.Braun Medical, 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.
- K093585: Microcyn Skin and Wound Hydrogel, Oculus Innovative Sciences, Inc. (2010) Summary page 4.

## Most influential descendants
- K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula (2015), 9 descendants of its own
- 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

## Indications for use
Rx: Under the supervision of a healthcare professional, PuriCore Wound Hydrogel Spray Dressing is intended for management of wounds, including itch and pain relief, and to cleanse and moisten the wound bed. A moist wound and skin environment is beneficial to the healing process. It is intended for use on mechanically or surgically debrided wounds, Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites, exit sites and intact skin, and various dermatoses, including contact dermatitis. It can be used during wound dressing changes to soften encrusted wound dressings. OTC: PuriCore Wound Hydrogel Spray Dressing is intended for use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, to cleanse and moisten the wound bed and for the management of minor cuts, exit sites and intact skin. It is also indicated for the management of minor irritation and pain from minor sunburn.

Source page: https://510kreport.com/device/K141863
Methodology: https://510kreport.com/methodology