510(k) · Cleared
ClearedCasrrasyn Oral Wound Dressing
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 Oct 11, 1995 after a 113-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Oct 11, 1995
- Review
- 113 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- Descendant · cites it directly · 17 of its ownK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- Descendant · cites it directly · 8 of its ownK063148 Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007
- Descendant · 2 generations on · 4 of its ownK210211 PuraStat-OM3-D Matrix, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK043587 Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006
- Descendant · 3 generations on · 3 of its ownK213552 PuraStat-RM3-D Matrix, Inc. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K012126The Salicept Oral PatchCarrington Laboratories, Inc. · 2001 · cites it directly17descendants
- K063148Sock IT! Oral Pain GelMerlin Group Dba Mcmerlin Dental Company · 2007 · cites it directly8descendants
- K210211PuraStat-OM3-D Matrix, Inc. · 2021 · 2 generations on4descendants
- K043587Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006 · 2 generations on4descendants
- K213552PuraStat-RM3-D Matrix, Inc. · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| +1 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| +1 | K063148 | Sock IT! Oral Pain Gel | Merlin Group Dba Mcmerlin Dental Company | 2007 | — |
| +2 | K210211 | PuraStat-OM | 3-D Matrix, Inc. | 2021 | — |
| +2 | K043587 | Sucralfate and Carafate Paste Kits | Patrick D. Mcgrath Ph.D | 2006 | — |
| +3 | K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 182 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, K012126 (Carrington Laboratories, Inc., 2001) has gone furthest, with 17 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 | — |
https://510kreport.com/device/K953423 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953423: Casrrasyn Oral Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953423
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026