510(k) · Cleared
ClearedUlceloocin Oral Ulcer Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunshine International Group, Inc. · OLR Oral Wound Dressing
Cleared on Jun 7, 2007 as substantially equivalent to K012126 (Carrington Laboratories, Inc., 2001) after a 72-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 7, 2007
- Review
- 72 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953423 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 1 generation backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- This deviceK070842 Ulceloocin Oral Ulcer PatchSunshine International Group, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK183436 OraCureTbm Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK260126 Curajel™ Oral GelUSpharma, Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −1 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| 0 (this device) | K070842 | Ulceloocin Oral Ulcer Patch | Sunshine International Group, Inc. | 2007 | — |
| +1 | K183436 | OraCure | Tbm Corporation | 2019 | — |
| +2 | K260126 | Curajel™ Oral Gel | USpharma, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K012126 | The Salicept Oral PatchSummary page 1…lceloocinTM Oral Ulcer Patch Common Name: Oral Wound Dressing Classification Name: Unclassified. PREDICATE DEVICE: The SaliCeptTM Oral Patch K012126 (Carrington Laboratories, Inc.) DEVICE DESCRIPTION: UlceloocinTM Oral Ulcer Patch is a vacuum-drie… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183436 | OraCure | 2019 | 1 |
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 12 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K183436 (Tbm Corporation, 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K012126.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
UlceloocinTM Oral Ulcer Patch 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/K070842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070842: Ulceloocin Oral Ulcer Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070842
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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