510(k) · Cleared
ClearedPluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, LP · FRO Dressing, Wound, Drug
Cleared on Mar 26, 2024 as substantially equivalent to K110172 (Stratus Pharmaceutical, 2011) after a 181-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Mar 26, 2024
- Review
- 181 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961758 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
- 4 generations backK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
- 3 generations backK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
- 2 generations backK082089 Prumyx CreamPrugen, Inc. · 2009
- 1 generation backK110172 Sonafine Wound DressingStratus Pharmaceutical · 2011
- This deviceK233151 PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and…Medline Industries, LP · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961758 | Carasyn Hydrogel Wound Products | Carrington Laboratories, Inc. | 1996 | — |
| −4 | K024367 | Sinclair Wound and Skin Emulsion | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −3 | K041342 | Impruv a.I. Cream Wound and Skin Emulsion | Stiefel Laboratories, Inc. | 2005 | — |
| −2 | K082089 | Prumyx Cream | Prugen, Inc. | 2009 | — |
| −1 | K110172 | Sonafine Wound Dressing | Stratus Pharmaceutical | 2011 | — |
| 0 (this device) | K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound… | Medline Industries, LP | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K110172 | Sonafine Wound DressingSummary page 4…ified Review Panel - General & Plastic Surgery Product Code - FRO Predicate Device Information Sonafine Wound Dressing - K110172 (Predicate) Reference Device Information Epiceram Skin Barrier Emulsion - K052643 (Reference device 1) Medline Burn and Wound Dr… | 2011 |
| † | K052643 | Epiceram | 2006 |
| † | K173911 | Medline Burn and Wound Dressing | 2018 |
| † | K190224 | Medline Burn and Wound Dressing (OTC) | 2019 |
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 28 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K110172.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Rx Indications for Use: PluroGel® Antimicrobial Burn and Wound Dressing is indicated for the management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites. PluroGel® Antimicrobial Burn and Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement…
Read the full statement (101 words)
Rx Indications for Use: PluroGel® Antimicrobial Burn and Wound Dressing is indicated for the management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites. PluroGel® Antimicrobial Burn and Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement of necrotic tissue.
OTC Indications for Use: PluroGel® Burn and Wound Dressing (OTC) is indicated for the management of minor cuts, minor burns, and minor lacerations. PluroGel® Burn and Wound Dressing (OTC) maintains a moist wound and skin environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233151 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233151: PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233151
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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