# K024180: Oramagicrx Oral Wound Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Mpm Medical., Inc.
- Decided: Mar 14, 2003 after 86 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
Longest line of descent: 1 generation back to K964852 (1997). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964852: Radiacare Oral Wound Rinse, Carrington Laboratories, Inc. (1997) Summary page 1.

## Most influential descendants
- K062795: Mugard Mucoadhesive Oral Wound Rinse (2006), 5 descendants of its own
- K140558: Proctigard (2014), 4 descendants of its own
- K213552: PuraStat-RM (2022), 3 descendants of its own
- K242634: PuraStat (2025), 2 descendants of its own
- K253923: PuraStat (2026), 1 descendant of its own

## Indications for use
For the management of oral mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers such as those caused by ill-fitting braces or dentures.

Source page: https://510kreport.com/device/K024180
Methodology: https://510kreport.com/methodology
