510(k) · Cleared
ClearedMuCover (proposed name) Oral Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MoleculeX Co., Ltd. · OLR Oral Wound Dressing
Cleared on May 21, 2026 as substantially equivalent to K211851 (Tbm Corporation, 2022) after a 174-day review. Its family tree reaches back 3 generations to 2011.
- Decided
- May 21, 2026
- Review
- 174 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K103054 (2011). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K211851 | Ora-AidSummary page 5…Oral Wound Dressing Regulatory Class: Unclassified Product Code: OLR, MGQ 3. Predicate Device: 510(k) number K211851 Device Name: Intra-oral Wound Dressing Trade Name: Ora-Aid Regulation Name:… | 2022 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 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?
Oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery. Oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.
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/K253816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253816: MuCover (proposed name) Oral Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253816
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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