510(k) · Cleared
ClearedCurajel™ Oral Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
USpharma, Ltd. · OLR Oral Wound Dressing
Cleared on Jun 15, 2026 as substantially equivalent to K183436 (Tbm Corporation, 2019) after a 151-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jun 15, 2026
- Review
- 151 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953423 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 3 generations backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- 2 generations backK070842 Ulceloocin Oral Ulcer PatchSunshine International Group, Inc. · 2007
- 1 generation backK183436 OraCureTbm Corporation · 2019
- This deviceK260126 Curajel™ Oral GelUSpharma, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −3 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| −2 | K070842 | Ulceloocin Oral Ulcer Patch | Sunshine International Group, Inc. | 2007 | — |
| −1 | K183436 | OraCure | Tbm Corporation | 2019 | — |
| 0 (this device) | K260126 | Curajel™ Oral Gel | USpharma, Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K183436 | OraCureSummary page 5…Name Oral Wound Dressing Classification Information Class: Unclassified Product Code: OLR Product Code Description: Oral Wound Dressing Predicate Device 510(k) Number: K183436 Trade/Proprietary/Model Name: OraCure Common/Usual Name: Oral Wound Dressing Product Code: OLR Class: Unclassified Applicant: TBM… | 2019 |
| † | K252425 | Silatrix Oral Gel | 2025 |
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 31 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Curajel™ Oral Gel is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260126: Curajel™ Oral Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260126
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026