510(k) · Cleared
ClearedProsit Wound Treatment Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silverleaf Medical Products, Inc. · FRO Dressing, Wound, Drug
Cleared on Dec 1, 2008 as substantially equivalent to K060237 (Silverleaf Medical Products, Inc., 2006) after a 143-day review. Its family tree reaches back 3 generations to 1992. 3 later devices descend from it.
- Decided
- Dec 1, 2008
- Review
- 143 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914579 (1992). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 2 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 1 generation backK060237 CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006
- This deviceK081977 Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK130350 ProcelleraVomaris Innovations, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK160783 ProcelleraVomaris Innovations, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK180533 Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −2 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −1 | K060237 | CMB Antimicrobial Dressing | Silverleaf Medical Products, Inc. | 2006 | — |
| 0 (this device) | K081977 | Prosit Wound Treatment Device | Silverleaf Medical Products, Inc. | 2008 | — |
| +1 | K130350 | Procellera | Vomaris Innovations, Inc. | 2013 | — |
| +1 | K160783 | Procellera | Vomaris Innovations, Inc. | 2016 | — |
| +1 | K180533 | Procellera Composite Antibacterial Wound Dressing | Vomaris Wound Care, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K060237 | CMB Antimicrobial DressingSummary page 1…or recipient graft sites. New Device Name: ProcelleraTM Predicate Device Name: CMVB Antimicrobial Dressing (K060237) Device Procellera TM is a single layer dressing consisting of a woven Description absorbent polyester fabric co… | 2006 |
What descends from it? (3)
3 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 16 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K130350 (Vomaris Innovations, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K060237.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
For professional use, ProcelleraTM antimicrobial wound dressing is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.
For over-the-counter use, ProcelleraTm wound dressing is indicated for minor cuts, scrapes, irritations, and arasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081977: Prosit Wound Treatment Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081977
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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