510(k) · Cleared

Recalled · 2006

Mucotrol Concentrated Oral Gel Wafer

K042400510(k) TraditionalCleared Nov 24, 200482-day reviewClass URecalls 1

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

Belcher Pharmaceuticals, Inc. · OLR Oral Wound Dressing

Cleared on Nov 24, 2004 as substantially equivalent to K013056 (Sinclair Pharmaceuticals, Ltd., 2001) and 1 other predicate after an 82-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.

Decided: Nov 24, 2004
Review: 82 days
Class: Class U
Product code: OLR
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K964852 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK964852 Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
This deviceK042400 Mucotrol Concentrated Oral Gel WaferBelcher Pharmaceuticals, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964852	Radiacare Oral Wound Rinse	Carrington Laboratories, Inc.	1997	—
0 (this device)	K042400	Mucotrol Concentrated Oral Gel Wafer	Belcher Pharmaceuticals, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K042400, 1997–2004Source: 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? (2)

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 …Wound & burn, Hydrogel with drug or biologic 3. IDevices to which new device is substantially equivalent: Sinclair Pharmaceuticals GelclairTM Concentrated Oral Gel (K(013056) and Carrington Labs RadiaCare TM Oral Wound Rinse (1K964852). 4. IDevice description: Belcher Pharmaceutical's Mucotrol~m co…	Sinclair Pharmaceuticals, Ltd.	2001	—
*	K964852	Radiacare Oral Wound Rinse Summary page 1 …o which new device is substantially equivalent: Sinclair Pharmaceuticals GelclairTM Concentrated Oral Gel (K(013056) and Carrington Labs RadiaCare TM Oral Wound Rinse (1K964852). 4. IDevice description: Belcher Pharmaceutical's Mucotrol~m concentrated oral gel wafer is compressed powder, presented as…	Carrington Laboratories, Inc.	1997	—

Also cleared against K013056: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 25, 2006	Not classified	Z-0398-2007	Other	Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
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.

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?

MUCOTROL T M CONCENTRATED ORAL GEL WAFER 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 8Y CHEMOTHERAPY OR RADIOTHERAPY), IRRITATION DUE TO ORAL SURGERY AND TRAUMATIC ULCERS CAUSED BY BRACES OR ILL FITTING DENTURES OR DISEASES. ALSO INDICATED FOR DIFFUSE APTHOUS ULCERS.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042400: Mucotrol Concentrated Oral Gel Wafer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042400

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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