# K133542: Puracyn Plus Skin and Wound

- Pathway: 510(k) (Traditional)
- Applicant: Innovacyn, Inc.
- Decided: Apr 28, 2014 after 161 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: 9 generations back to K914579 (1992). 43 ancestors in all.
14 later devices descend from it; 4 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)
- K093697: Vashe Wound Therapy Solution, Puricore, Inc. (2010) Summary page 1.
- K123072: Vashe Wound Therapy Solution, Puricore, Inc. (2013) Summary page 1.
- K113693: Nixall TM Wound and Skin Care, Seriously Clean, Ltd. (2012)

## Most influential descendants
- K181428: Clyra Wound Irrigation Solution (2019), 5 descendants of its own
- K202071: SURGIPHOR Wound Irrigation System (2020), 4 descendants of its own
- K142592: CleanSmart Wound Cleanser (2015), 4 descendants of its own
- K213616: BD Surgiphor Antimicrobial Irrigation System (2022), 3 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

## Indications for use
OTC: Puracyn PlusTM Skin and Wound Care is intended for the OTC use of the management of minor skin wounds including minor lacerations, minor abrasions, minor irritations, minor cuts, minor burns and intact skin, in addition to moistening and lubricating absorbent wound dressings. Professional Use: Puracyn PlusTM Skin and Wound Care is intended for use by healthcare professionals for cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post-surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.

Source page: https://510kreport.com/device/K133542
Methodology: https://510kreport.com/methodology