510(k) · Cleared
ClearedOramagicrx Oral Wound Rinse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mpm Medical., Inc. · OLR Oral Wound Dressing
Cleared on Mar 14, 2003 as substantially equivalent to K964852 (Carrington Laboratories, Inc., 1997) after an 86-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.
- Decided
- Mar 14, 2003
- Review
- 86 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964852 (1997). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964852 Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
- This deviceK024180 Oramagicrx Oral Wound RinseMpm Medical., Inc. · 2003
- Descendant · cites it directly · 5 of its ownK062795 Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK140558 ProctigardAccess Pharmaceuticals, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK213552 PuraStat-RM3-D Matrix, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK242634 PuraStat3-D Matrix Europe SAS · 2025
- Descendant · 5 generations on · 1 of its ownK253923 PuraStat3-D Matrix Europe SAS · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062795Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006 · cites it directly5descendants
- K140558ProctigardAccess Pharmaceuticals, Inc. · 2014 · 2 generations on4descendants
- K213552PuraStat-RM3-D Matrix, Inc. · 2022 · 3 generations on3descendants
- K242634PuraStat3-D Matrix Europe SAS · 2025 · 4 generations on2descendants
- K253923PuraStat3-D Matrix Europe SAS · 2026 · 5 generations on1descendant
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) | K024180 | Oramagicrx Oral Wound Rinse | Mpm Medical., Inc. | 2003 | — |
| +1 | K062795 | Mugard Mucoadhesive Oral Wound Rinse | Access Pharmaceuticals, Inc. | 2006 | — |
| +2 | K140558 | Proctigard | Access Pharmaceuticals, Inc. | 2014 | — |
| +3 | K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022 | — |
| +4 | K242634 | PuraStat | 3-D Matrix Europe SAS | 2025 | — |
| +5 | K253923 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 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? (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 | Decided |
|---|---|---|---|
| * | K964852 | Radiacare Oral Wound RinseSummary page 1…s Oral Rinse Classification Name: Dressing, Wound and Burn, Hydrogel w/ Drug and/or Biologic 111. PREDICATE DEVICE Radiacare'" Oral Wound Rinse (K964852 Carrington Laboratories, Inc.) IV. DEVICE DESCRIPTION OraMagicRx'" Oral Wound Rinse is a wound dressing designed for th… | 1997 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
For the management of oral mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers such as those caused by ill-fitting braces or dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024180 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024180: Oramagicrx Oral Wound Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024180
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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