# K964852: Radiacare Oral Wound Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Carrington Laboratories, Inc.
- Decided: Mar 3, 1997 after 90 days
- Product code: OLR (Oral Wound Dressing)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Carrasyn® Oral Wound Dressing: named in the summary without a submission number
- (no number) Carrington Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K063148: Sock IT! Oral Pain Gel (2007), 8 descendants of its own
- K024180: Oramagicrx Oral Wound Rinse (2003), 7 descendants of its own
- K062795: Mugard Mucoadhesive Oral Wound Rinse (2006), 5 descendants of its own
- K210211: PuraStat-OM (2021), 4 descendants of its own
- K140558: Proctigard (2014), 4 descendants of its own

## Indications for use
RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis.

Source page: https://510kreport.com/device/K964852
Methodology: https://510kreport.com/methodology