# K213514: Spectricept Skin and Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
- Decided: Jan 13, 2023 after 437 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: 12 generations back to K914579 (1992). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161034: Microcyn Plus Wound Care Solution, Oculus Innovative Sciences (2016) Summary page 4.

## Most influential descendants
- K243875: Spectricept Skin and Wound Cleanser (2025), 0 descendants of its own

## Indications for use
Spectricept Skin and Wound Cleanser for Professional Use: Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. Spectricept Skin and Wound Cleanser for OTC Use: Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from of skin abrasions, lacerations, minor irritations, cuts and intact skin.

Source page: https://510kreport.com/device/K213514
Methodology: https://510kreport.com/methodology