510(k) · Cleared
ClearedRadiacare Oral Wound Rinse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carrington Laboratories, Inc. · OLR Oral Wound Dressing
Cleared on Mar 3, 1997 after a 90-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- Mar 3, 1997
- Review
- 90 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 4 citing it directly.
- This deviceK964852 Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
- Descendant · cites it directly · 8 of its ownK063148 Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007
- Descendant · cites it directly · 7 of its ownK024180 Oramagicrx Oral Wound RinseMpm Medical., Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK062795 Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK210211 PuraStat-OM3-D Matrix, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK140558 ProctigardAccess Pharmaceuticals, Inc. · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K063148Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007 · cites it directly8descendants
- K024180Oramagicrx Oral Wound RinseMpm Medical., Inc. · 2003 · cites it directly7descendants
- K062795Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006 · 2 generations on5descendants
- K210211PuraStat-OM3-D Matrix, Inc. · 2021 · 2 generations on4descendants
- K140558ProctigardAccess Pharmaceuticals, Inc. · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964852 | Radiacare Oral Wound Rinse | Carrington Laboratories, Inc. | 1997 | — |
| +1 | K063148 | Sock IT! Oral Pain Gel | Merlin Group Dba Mcmerlin Dental Company | 2007 | — |
| +1 | K024180 | Oramagicrx Oral Wound Rinse | Mpm Medical., Inc. | 2003 | — |
| +2 | K062795 | Mugard Mucoadhesive Oral Wound Rinse | Access Pharmaceuticals, Inc. | 2006 | — |
| +2 | K210211 | PuraStat-OM | 3-D Matrix, Inc. | 2021 | — |
| +3 | K140558 | Proctigard | Access Pharmaceuticals, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | — | Carrasyn® Oral Wound Dressing Named without a submission number | |
| * | — | Carrington Wound Dressing Named without a submission number |
What descends from it? (15)
See all 154 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?
- Of its descendants, K063148 (Merlin Group Dba Mcmerlin Dental Company, 2007) has gone furthest, with 8 descendants of its own.
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?
RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis.
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/K964852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964852: Radiacare Oral Wound Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964852
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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