510(k) · Cleared
ClearedProthelial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mueller Medical International, LLC · FRO Dressing, Wound, Drug
Cleared on Aug 7, 2013 as substantially equivalent to K043587 (Patrick D. Mcgrath Ph.D, 2006) and 1 other predicate after a 231-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 7, 2013
- Review
- 231 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953423 (1995). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK953423 Casrrasyn Oral Wound DressingCarrington Laboratories, Inc. · 1995
- 3 generations backK012126 The Salicept Oral PatchCarrington Laboratories, Inc. · 2001
- 2 generations backK043587 Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006
- 1 generation backK082856 Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 2008
- This deviceK123904 ProthelialMueller Medical International, LLC · 2013
- Descendant · cites it directly · 1 of its ownK202000 Silatrix Oral GelSa3, LLC · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK252425 Silatrix Oral GelSa3, LLC · 2025
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 |
|---|---|---|---|---|---|
| −4 | K953423 | Casrrasyn Oral Wound Dressing | Carrington Laboratories, Inc. | 1995 | — |
| −3 | K012126 | The Salicept Oral Patch | Carrington Laboratories, Inc. | 2001 | — |
| −2 | K043587 | Sucralfate and Carafate Paste Kits | Patrick D. Mcgrath Ph.D | 2006 | — |
| −1 | K082856 | Carapaste Oral Wound Dressing | Mcgrath Pharmaceuticals, Inc. | 2008 | — |
| 0 (this device) | K123904 | Prothelial | Mueller Medical International, LLC | 2013 | — |
| +1 | K202000 | Silatrix Oral Gel | Sa3, LLC | 2020 | 1 |
| +2 | K252425 | Silatrix Oral Gel | Sa3, LLC | 2025 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 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 |
|---|---|---|---|
| * | K043587 | Sucralfate and Carafate Paste KitsSummary page 1…fied 3. Devices to Which New Device is Substantially Equivalent ProThelial M & Orafate Sucralfate Paste is a hydrogel wound dressing that is substantially equivalent to K043587 Sucralfate HCI Topical Paste and K082856 Carapaste® Oral Wound Dressing. Its substantial equivalence is based firstly on sucralfa… | 2006 |
| * | K082856 | Carapaste Oral Wound DressingSummary page 1…ubstantially Equivalent ProThelial M & Orafate Sucralfate Paste is a hydrogel wound dressing that is substantially equivalent to K043587 Sucralfate HCI Topical Paste and K082856 Carapaste® Oral Wound Dressing. Its substantial equivalence is based firstly on sucralfate being the active ingredient for each o… | 2008 |
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 |
|---|---|---|---|
| K202000 | Silatrix Oral Gel | 2020 | 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 18 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K202000 (Sa3, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K043587.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
ProTheliarIM & Orafate Sucralfate Malate Paste forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123904: Prothelial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123904
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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