510(k) · Cleared
ClearedGelclair Concentrated Oral Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinclair Pharmaceuticals, Ltd. · OLR Oral Wound Dressing
Cleared on Dec 21, 2001 after a 101-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- Dec 21, 2001
- Review
- 101 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 9 citing it directly.
- This deviceK013056 Gelclair Concentrated Oral GelSinclair Pharmaceuticals, Ltd. · 2001
- Descendant · cites it directly · 5 of its ownK062795 Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK023155 Aloclair Oral RinseSinclair Pharmaceuticals, Ltd. · 2002
- Descendant · 2 generations on · 4 of its ownK140558 ProctigardAccess Pharmaceuticals, Inc. · 2014
- Descendant · cites it directly · 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 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K062795Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006 · cites it directly5descendants
- K023155Aloclair Oral RinseSinclair Pharmaceuticals, Ltd. · 2002 · cites it directly5descendants
- K140558ProctigardAccess Pharmaceuticals, Inc. · 2014 · 2 generations on4descendants
- K043587Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006 · cites it directly4descendants
- 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) | K013056 | Gelclair Concentrated Oral Gel | Sinclair Pharmaceuticals, Ltd. | 2001 | — |
| +1 | K062795 | Mugard Mucoadhesive Oral Wound Rinse | Access Pharmaceuticals, Inc. | 2006 | — |
| +1 | K023155 | Aloclair Oral Rinse | Sinclair Pharmaceuticals, Ltd. | 2002 | — |
| +2 | K140558 | Proctigard | Access Pharmaceuticals, Inc. | 2014 | — |
| +1 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | — | Carrington Laboratories Radiacare™ Oral Wound Rinse Named without a submission number |
What descends from it? (21)
See all 219 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062795 | Mugard Mucoadhesive Oral Wound Rinse | 2006 | 5 |
| K023155 | Aloclair Oral Rinse | 2002 | 5 |
| K043587 | Sucralfate and Carafate Paste Kits | 2006 | 4 |
| K040950 | Aloclair Oral Gel | 2004 | 3 |
| K081372 | Gelx Oral Gel | 2009 | 1 |
| K053342 | Gengigel Mouthrinse | 2007 | 1 |
| K101769 | Episil | 2011 | 0 |
| K082553 | Rexastom Oral Ease | 2008 | 0 |
| K042400 | Mucotrol Concentrated Oral Gel Wafer | 2004 | 0 |
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, K062795 (Access Pharmaceuticals, Inc., 2006) has gone furthest, with 5 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?
Sinclair Gelclair® CONCENTRATED ORAL GEL, has a
mechanical action indicated for the management of pain and
relief of pain, by adhering to the mucosal surface of the mouth,
soothing oral lesions of various etiologies, including: Oral
Mucositis/Stomatitis (may be caused by chemotherapy or
radiotherapy), iritation due to oral surgery and traumatic ulcers
caused by braces or ill fitting dentures or disease. Also
indicated also for diffuse aphthous ulcers.
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/K013056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013056: Gelclair Concentrated Oral Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013056
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026