510(k) · Cleared

Cleared

MucoLock Oral Gel

K203091510(k) TraditionalCleared Feb 12, 2021122-day reviewClass U

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

Pcca, Inc. · OLR Oral Wound Dressing

Cleared on Feb 12, 2021 as substantially equivalent to K081372 (Bmg Pharma, LLC, 2009) after a 122-day review. Its family tree reaches back 2 generations to 2001.

Decided: Feb 12, 2021
Review: 122 days
Class: Class U
Product code: OLR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K013056 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK013056 Gelclair Concentrated Oral GelSinclair Pharmaceuticals, Ltd. · 2001
1 generation backK081372 Gelx Oral GelBmg Pharma, LLC · 2009
This deviceK203091 MucoLock Oral GelPcca, Inc. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K013056	Gelclair Concentrated Oral Gel	Sinclair Pharmaceuticals, Ltd.	2001	—
−1	K081372	Gelx Oral Gel	Bmg Pharma, LLC	2009	—
0 (this device)	K203091	MucoLock Oral Gel	Pcca, Inc.	2021	—

FIG. 1 — Lineage of K203091, 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
*	K081372	Gelx Oral Gel Summary page 4 …Name: MucoLock® Oral Gel Classification: Oral Wound Dressing Regulatory class: I, Unclassified Product Code: OLR Legally Marketed Device: K081372 - GELX Oral Gel Device Description: MucoLock® is a low viscosity, pourable, and swish-able gel, which is presented in 16 fl. oz.…	Bmg Pharma, LLC	2009	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All OLR devices

OLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?

MucoLock has a mechanical action which provides 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 or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces and ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K203091 · printed Nov 4, 2026

Cite this page

510(k) Report. “K203091: MucoLock 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/K203091

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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