510(k) Report

510(k) · Cleared

Cleared

Procellera Composite Antibacterial Wound Dressing

K180533510(k) TraditionalCleared Dec 10, 2018285-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vomaris Wound Care, Inc. · FRO Dressing, Wound, Drug

Cleared on Dec 10, 2018 as substantially equivalent to K160783 (Vomaris Innovations, Inc., 2016) and 4 other predicates after a 285-day review. Its family tree reaches back 6 generations to 1992.

Decided
Dec 10, 2018
Review
285 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K914579 (1992). 25 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2016: 1 other ancestor2013: 1 other ancestor2008: 2 other ancestors2006: 1 other ancestor2004: 1 other ancestor1997: 3 other ancestors2009: 1 other ancestor1995: 1 other ancestor2007: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1999: 1 other ancestor1989: 1 other ancestor1992: 1 other ancestorK914579 · Silver Foam Wound Dressing · Vitaphore Corp. · 1992K955453 · Acticoat Silver Coated Dressing · Westaim Technologies, Inc. · 1996K981299 · Silverlon Contact Wound Dressing · Argentum International, LLC · 1998K984208 · Silverlon Island Dressing, Silverlon Island Pad · Argentum International, LLC · 1999K122817 · Silverlon Island Wound Dressing · Argentum Medical, LLC · 2014K143001 · Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing · Argentum Medical · 201419851990199520002005201020152020
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors4 generations back: 5 other ancestors5 generations back: 3 other ancestors6 generations back: 1 other ancestor K143001 · Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing · Argentum Medical · 2014K122817 · Silverlon Island Wound Dressing · Argentum Medical, LLC · 2014K984208 · Silverlon Island Dressing, Silverlon Island Pad · Argentum International, LLC · 1999K981299 · Silverlon Contact Wound Dressing · Argentum International, LLC · 1998K955453 · Acticoat Silver Coated Dressing · Westaim Technologies, Inc. · 1996K914579 · Silver Foam Wound Dressing · Vitaphore Corp. · 1992−50
  1. Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
  2. 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
  3. 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
  4. 3 generations backK984208 Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC · 1999
  5. 2 generations backK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
  6. 1 generation backK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
  7. This deviceK180533 Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K914579Silver Foam Wound DressingVitaphore Corp.1992—
−5K955453Acticoat Silver Coated DressingWestaim Technologies, Inc.1996—
−4K981299Silverlon Contact Wound DressingArgentum International, LLC1998—
−3K984208Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC1999—
−2K122817Silverlon Island Wound DressingArgentum Medical, LLC2014—
−1K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical2014—
0 (this device)K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199210
199410
199510
199730
199810
199910
200010
200410
200610
200710
200820
200910
201310
201610
FIG. 1 — Lineage of K180533, 1992–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K160783Procellera
Summary page 4
…nd Classification: FRO, Unclassified Primary Predicate Device: Procellera Antimicrobial Wound Dressing (K160783, K130350, K081977, K060237) Secondary Predicate Device: Silverlon Island Wound Dressing (K143001) Intended Use Fo…
Vomaris Innovations, Inc.2016—
*K130350Procellera
Summary page 4
…fication: FRO, Unclassified Primary Predicate Device: Procellera Antimicrobial Wound Dressing (K160783, K130350, K081977, K060237) Secondary Predicate Device: Silverlon Island Wound Dressing (K143001) Intended Use For profess…
Vomaris Innovations, Inc.2013—
*K081977Prosit Wound Treatment Device
Summary page 4
…FRO, Unclassified Primary Predicate Device: Procellera Antimicrobial Wound Dressing (K160783, K130350, K081977, K060237) Secondary Predicate Device: Silverlon Island Wound Dressing (K143001) Intended Use For professional use…
Silverleaf Medical Products, Inc.2008—
*K060237CMB Antimicrobial Dressing
Summary page 4
…FRO, Unclassified Primary Predicate Device: Procellera Antimicrobial Wound Dressing (K160783, K130350, K081977, K060237) Secondary Predicate Device: Silverlon Island Wound Dressing (K143001) Intended Use For professional use, Procell…
Silverleaf Medical Products, Inc.2006—
*K143001Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing
Summary page 4
…Wound Dressing (K160783, K130350, K081977, K060237) Secondary Predicate Device: Silverlon Island Wound Dressing (K143001) Intended Use For professional use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds…
Argentum Medical2014—

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 26 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
  • 1 of the 25 ancestors has a recall of any class.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

For professional use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc.

For over-the-counter use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc.

Indications for use as stated in the FDA summary.

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K180533 · printed Nov 5, 2026

Cite this page

510(k) Report. “K180533: Procellera Composite Antibacterial Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180533

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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