510(k) · Cleared

Cleared

Gelx Oral Gel

K081372510(k) TraditionalCleared Feb 4, 2009264-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bmg Pharma, LLC · OLR Oral Wound Dressing

Cleared on Feb 4, 2009 as substantially equivalent to K013056 (Sinclair Pharmaceuticals, Ltd., 2001) after a 264-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Feb 4, 2009
Review: 264 days
Class: Class U
Product code: OLR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K013056 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK013056 Gelclair Concentrated Oral GelSinclair Pharmaceuticals, Ltd. · 2001
This deviceK081372 Gelx Oral GelBmg Pharma, LLC · 2009
Descendant · cites it directly · 0 of its ownK203091 MucoLock Oral GelPcca, Inc. · 2021

Most influential descendants

Showing 1 of 1 · See all

K203091MucoLock Oral GelPcca, Inc. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K013056	Gelclair Concentrated Oral Gel	Sinclair Pharmaceuticals, Ltd.	2001	—
0 (this device)	K081372	Gelx Oral Gel	Bmg Pharma, LLC	2009	—
+1	K203091	MucoLock Oral Gel	Pcca, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K081372, 2001–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OLR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OLR device

#1 K253758 Dental Cone; Dental Spongescore 13.2 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K013056	Gelclair Concentrated Oral Gel Summary page 1 …BMG Pharma's GeiX® ORAL GEL has the same intended/indications for use as the predicate Sinclair Pharmaceuticals, Ltd., Gelclair® Concentrated Oral Gel (K013056). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service %…	Sinclair Pharmaceuticals, Ltd.	2001	—

Also cleared against K013056: 8 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K203091	MucoLock Oral Gel	Pcca, Inc.	2021	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K203091 (Pcca, Inc., 2021) has gone furthest, with 0 descendants of its own.
8 other devices also cite its predicate K013056.

How does its category compare?

All OLR devices

OLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · OLR

4so far in 2026, the most since 2007

2007high 4 (2026) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLR

83in 2025

2007high 188 (2026) · low 83 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLR

1in 2022

2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OLR

5in 2025

2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	93	0	0
2008	2	—	0	0
2009	2	—	0	0
2010	0	—	0	0
2011	3	115	0	0
2012	1	—	0	0
2013	0	—	0	0
2014	1	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	2	—	0	0
2020	2	—	0	0
2021	2	—	0	0
2022	2	—	1	0
2023	1	—	0	0
2024	0	—	0	0
2025	3	83	0	5
2026	4	188	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081372 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081372: Gelx Oral Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081372

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026