510(k) · Cleared
ClearedSucralfate and Carafate Paste Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patrick D. Mcgrath Ph.D · FRO Dressing, Wound, Drug
Cleared on Feb 3, 2006 as substantially equivalent to K013056 (Sinclair Pharmaceuticals, Ltd., 2001) and 1 other predicate after a 402-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 402 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953423 (1995). 3 ancestors in all. 4 later devices descend from it, 2 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 deviceK043587 Sucralfate and Carafate Paste KitsPatrick D. Mcgrath Ph.D · 2006
- Descendant · cites it directly · 3 of its ownK082856 Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK123904 ProthelialMueller Medical International, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK202000 Silatrix Oral GelSa3, LLC · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK252425 Silatrix Oral GelSa3, LLC · 2025
Most influential descendants
Showing 4 of 4 · See all- K082856Carapaste Oral Wound DressingMcgrath Pharmaceuticals, Inc. · 2008 · cites it directly3descendants
- K123904ProthelialMueller Medical International, LLC · 2013 · cites it directly2descendants
- K202000Silatrix Oral GelSa3, LLC · 2020 · 2 generations on1descendant
- K252425Silatrix Oral GelSa3, LLC · 2025 · 3 generations on0descendants
View 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) | K043587 | Sucralfate and Carafate Paste Kits | Patrick D. Mcgrath Ph.D | 2006 | — |
| +1 | K082856 | Carapaste Oral Wound Dressing | Mcgrath Pharmaceuticals, Inc. | 2008 | — |
| +1 | K123904 | Prothelial | Mueller Medical International, LLC | 2013 | — |
| +2 | K202000 | Silatrix Oral Gel | Sa3, LLC | 2020 | 1 |
| +3 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K013056 | Gelclair Concentrated Oral GelSummary page 1…Biologic Product Code: RC Classification: Unclassified .3. Devices to Which New Device is Substantially Equivalent Gelelair Concentrated Oral Gel K013056 Salicept Oral Patch K012126 4. Device Description Sucralfate HCI Topical Paste 'mis an amorphous hydrogel paste formed… | 2001 |
| * | K012126 | The Salicept Oral PatchSummary page 1…Classification: Unclassified .3. Devices to Which New Device is Substantially Equivalent Gelelair Concentrated Oral Gel K013056 Salicept Oral Patch K012126 4. Device Description Sucralfate HCI Topical Paste 'mis an amorphous hydrogel paste formed by the controlled reaction of sucral… | 2001 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082856 (Mcgrath Pharmaceuticals, Inc., 2008) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K013056.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Sucralfate HCI Topical 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. This 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/K043587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043587: Sucralfate and Carafate Paste Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043587
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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