510(k) · Cleared
ClearedOraCure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tbm Corporation · OLR Oral Wound Dressing
Cleared on Sep 18, 2019 as substantially equivalent to K070842 (Sunshine International Group, Inc., 2007) after a 281-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Sep 18, 2019
- Review
- 281 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953423 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 2 generations backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- 1 generation backK070842 Ulceloocin Oral Ulcer PatchSunshine International Group, Inc. · 2007
- This deviceK183436 OraCureTbm Corporation · 2019
- Descendant · cites it directly · 0 of its ownK260126 Curajel™ Oral GelUSpharma, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260126Curajel™ Oral GelUSpharma, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −2 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| −1 | K070842 | Ulceloocin Oral Ulcer Patch | Sunshine International Group, Inc. | 2007 | — |
| 0 (this device) | K183436 | OraCure | Tbm Corporation | 2019 | — |
| +1 | K260126 | Curajel™ Oral Gel | USpharma, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K070842 | Ulceloocin Oral Ulcer PatchSummary page 4…e Manufacturer Sunshine International Group, Inc., Device Name (Trade Name) UlceloocinTM Oral Ulcer Patch 510(k) Number K070842 Page 1 4. SUBJECT DEVICE DESCRIPTION OraCure® is an oral wound… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260126 | Curajel™ Oral Gel | 2026 | 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?
- The line of descent spans 24 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.
- Of its descendants, K260126 (USpharma, Ltd., 2026) has gone furthest, with 0 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. 2019, 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?
OraCure® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183436: OraCure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183436
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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