510(k) · Cleared
ClearedMugard Mucoadhesive Oral Wound Rinse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Pharmaceuticals, Inc. · OLR Oral Wound Dressing
Cleared on Dec 11, 2006 as substantially equivalent to K024180 (Mpm Medical., Inc., 2003) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Dec 11, 2006
- Review
- 84 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964852 (1997). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK964852 Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
- 1 generation backK024180 Oramagicrx Oral Wound RinseMpm Medical., Inc. · 2003
- This deviceK062795 Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK140558 ProctigardAccess Pharmaceuticals, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK213552 PuraStat-RM3-D Matrix, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK242634 PuraStat3-D Matrix Europe SAS · 2025
- Descendant · 4 generations on · 1 of its ownK253923 PuraStat3-D Matrix Europe SAS · 2026
- Descendant · 3 generations on · 0 of its ownK261504 PuraStat-RM3-D Matrix, Inc. · 2026
Most influential descendants
Showing 5 of 5 · See all- K140558ProctigardAccess Pharmaceuticals, Inc. · 2014 · cites it directly4descendants
- K213552PuraStat-RM3-D Matrix, Inc. · 2022 · 2 generations on3descendants
- K242634PuraStat3-D Matrix Europe SAS · 2025 · 3 generations on2descendants
- K253923PuraStat3-D Matrix Europe SAS · 2026 · 4 generations on1descendant
- K261504PuraStat-RM3-D Matrix, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964852 | Radiacare Oral Wound Rinse | Carrington Laboratories, Inc. | 1997 | — |
| −1 | K024180 | Oramagicrx Oral Wound Rinse | Mpm Medical., Inc. | 2003 | — |
| 0 (this device) | K062795 | Mugard Mucoadhesive Oral Wound Rinse | Access Pharmaceuticals, Inc. | 2006 | — |
| +1 | K140558 | Proctigard | Access Pharmaceuticals, Inc. | 2014 | — |
| +2 | K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022 | — |
| +3 | K242634 | PuraStat | 3-D Matrix Europe SAS | 2025 | — |
| +4 | K253923 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
| +3 | K261504 | PuraStat-RM | 3-D Matrix, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K024180 | Oramagicrx Oral Wound RinseSummary page 1…lent to the following predicate devices: * OraMagicRxTM Oral Wound Rinse manufactured by MPM Medical, Inc. and cleared for commercial distribution under 510(k) K024180. * Gelclair Concentrated Oral Gel manufactured by Sinclair Pharmaceuticals, Ltd. and cleared for commercial distributio… | 2003 |
| * | K013056 | Gelclair Concentrated Oral Gel | 2001 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140558 | Proctigard | 2014 | 4 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140558 (Access Pharmaceuticals, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K024180.
How does its category compare?
All OLR devicesOLR 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
2026 to Oct 25, outlined.
Median 510(k) review, days · OLR
83in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLR
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLR
5in 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?
MuGardTM Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062795 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062795: Mugard Mucoadhesive Oral Wound Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062795
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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