# K081372: Gelx Oral Gel

- Pathway: 510(k) (Traditional)
- Applicant: Bmg Pharma, LLC
- Decided: Feb 4, 2009 after 264 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 K013056 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013056: Gelclair Concentrated Oral Gel, Sinclair Pharmaceuticals, Ltd. (2001) Summary page 1.

## Most influential descendants
- K203091: MucoLock Oral Gel (2021), 0 descendants of its own

## Indications for use
BMG Pharma's GeIX® ORAL GEL has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

Source page: https://510kreport.com/device/K081372
Methodology: https://510kreport.com/methodology