# K070463: Revera Wound Care, Model MDW0060

- Pathway: 510(k) (Traditional)
- Applicant: Revalesio Corporation
- Decided: May 7, 2008 after 446 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: 4 generations back to K945802 (1995). 6 ancestors in all.
22 later devices descend from it; 2 cite it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005) Summary page 1.
- K041161: Microcyn Wound Care Dressing, Oculus Innovative Sciences, Inc. (2005) Summary page 1.

## Most influential descendants
- K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 (2008), 13 descendants of its own
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K083042: Wound Flush, Sterile Water & Normal Saline (2008), 7 descendants of its own
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own

## Indications for use
REVERATM Wound Care is indicated for moisiening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin, in addition to moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor bums.

Source page: https://510kreport.com/device/K070463
Methodology: https://510kreport.com/methodology