510(k) · Cleared
ClearedAloclair Oral Rinse
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 Nov 25, 2002 as substantially equivalent to K013056 (Sinclair Pharmaceuticals, Ltd., 2001) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Nov 25, 2002
- Review
- 63 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983182 (1998). 2 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK983182 Aloe Therapy Oral RinseCarrington Laboratories, Inc. · 1998
- This deviceK023155 Aloclair Oral RinseSinclair Pharmaceuticals, Ltd. · 2002
- Descendant · cites it directly · 3 of its ownK040950 Aloclair Oral GelSinclair Pharmaceuticals, Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK042722 Aloclair Oral SpraySinclair Pharmaceuticals, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK053342 Gengigel MouthrinseRicerfarma Srl · 2007
- Descendant · 2 generations on · 0 of its ownK130959 Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield…Bioplax Limited · 2014
- Descendant · cites it directly · 0 of its ownK082553 Rexastom Oral EaseRexaderm, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K040950Aloclair Oral GelSinclair Pharmaceuticals, Ltd. · 2004 · cites it directly3descendants
- K042722Aloclair Oral SpraySinclair Pharmaceuticals, Ltd. · 2005 · cites it directly2descendants
- K053342Gengigel MouthrinseRicerfarma Srl · 2007 · cites it directly1descendant
- K130959Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior GelBioplax Limited · 2014 · 2 generations on0descendants
- K082553Rexastom Oral EaseRexaderm, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983182 | Aloe Therapy Oral Rinse | Carrington Laboratories, Inc. | 1998 | — |
| 0 (this device) | K023155 | Aloclair Oral Rinse | Sinclair Pharmaceuticals, Ltd. | 2002 | — |
| +1 | K040950 | Aloclair Oral Gel | Sinclair Pharmaceuticals, Ltd. | 2004 | — |
| +1 | K042722 | Aloclair Oral Spray | Sinclair Pharmaceuticals, Ltd. | 2005 | — |
| +1 | K053342 | Gengigel Mouthrinse | Ricerfarma Srl | 2007 | — |
| +2 | K130959 | Aftamed Mouthwash; Aftamed Gel; Aftamed Spray; Aftamed Shield; Aftamed Junior… | Bioplax Limited | 2014 | — |
| +1 | K082553 | Rexastom Oral Ease | Rexaderm, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 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 Gel | 2001 |
| * | K983182 | Aloe Therapy Oral RinseSummary page 1…New Device is Substantially Equivalent: Sinclair Gelclair Concentrated Oral Gel cleared in 51 O(k) KO1 3056 AloeCeuticals (Carrington Lab) OraRinse cleared in 51 O(k) K983182 4. Device Description: ALOCLAIR~~ ORALRINSE is a viscous gel formulation, which is presented for over-the- counter use premixed… | 1998 |
What descends from it? (5)
4 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?
SINCLAIR ALOCLAIR™ ORAL with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023155: Aloclair Oral Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023155
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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