510(k) · Cleared
ClearedRexastom Oral Ease
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rexaderm, Inc. · OLR Oral Wound Dressing
Cleared on Nov 21, 2008 as substantially equivalent to K013056 (Sinclair Pharmaceuticals, Ltd., 2001) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Nov 21, 2008
- Review
- 79 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983182 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983182 | Aloe Therapy Oral Rinse | Carrington Laboratories, Inc. | 1998 | — |
| −1 | K023155 | Aloclair Oral Rinse | Sinclair Pharmaceuticals, Ltd. | 2002 | — |
| 0 (this device) | K082553 | Rexastom Oral Ease | Rexaderm, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 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 |
|---|---|---|---|
| * | K013056 | Gelclair Concentrated Oral GelSummary page 1…and Bum, Hydrogel w/Drug or Biologic 3. Devices to Which New Device is Substantially Equivalent: Gelclair Concentrated Oral Gel, Sinclair lharmaceuticals K013056 Aloclair Oral Rinse, Sinclair Pharmaceult icals K023155 4. Device Description: RexaStom Oral Ease is a dr… | 2001 |
| * | K023155 | Aloclair Oral RinseSummary page 1…antially Equivalent: Gelclair Concentrated Oral Gel, Sinclair lharmaceuticals K013056 Aloclair Oral Rinse, Sinclair Pharmaceult icals K023155 4. Device Description: RexaStom Oral Ease is a dry, wafer or matrix tyl::e material, similar to coarse blotting paper. For muco… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 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.
- 8 other devices also cite its predicate K013056.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
RexaStom Oral Ease has a mechanical barrier action indicated for the temporary relief of pain by adhering to the mucosal surface of the mouth, covering and soothing oral lesions of various etiologies. The lesions include oral mucositis resulting from chemo- or radiation therapy, stomatitis, irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, aphthous ulcers, or other diseases or conditions of the oral mucous surfaces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082553: Rexastom Oral Ease.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082553
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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