510(k) · Cleared
ClearedBrennen Medical Silver Glucan Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brennen Medical, Inc. · FRO Dressing, Wound, Drug
Cleared on Feb 17, 2006 as substantially equivalent to K955453 (Westaim Technologies, Inc., 1996) and 7 other predicates after a 400-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Feb 17, 2006
- Review
- 400 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to K914579 (1992). 13 ancestors in all, the oldest K820198 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 2 generations backK983833 Acticoat Composite Wound Dressing, Acticoat Composite Wound…Westaim Biomedical, Inc. · 1998
- 1 generation backK992221 Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
- This deviceK050086 Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −3 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −2 | K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive | Westaim Biomedical, Inc. | 1998 | — |
| −1 | K992221 | Acticoat Primary Antimicrobial Dressing | Westaim Biomedical, Inc. | 2000 | — |
| 0 (this device) | K050086 | Brennen Medical Silver Glucan Wound Dressing | Brennen Medical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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? (8)
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 |
|---|---|---|---|
| * | K955453 | Acticoat Silver Coated DressingSummary page 2…hat is in commercial distribution and is presently marketed by Westaim Medical (now under the name of Smith-Nephew) and previously reviewed by ODE under 510(k) K955453; and Silverlon Contact Wound Dressing reviewed on K981299. Both were found substantially equivalcnt. Also, the followi… | 1996 |
| * | K981299 | Silverlon Contact Wound DressingSummary page 2…d by Westaim Medical (now under the name of Smith-Nephew) and previously reviewed by ODE under 510(k) K955453; and Silverlon Contact Wound Dressing reviewed on K981299. Both were found substantially equivalcnt. Also, the following predicate device(s) contain silver or glucan and have b… | 1998 |
| * | K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-AdhesiveSummary page 2…ce(s) contain silver or glucan and have been reviewed by ODE and found substantially equivalent The predicate devices are: I. Acticoat Silver Coated Dressing (K983833. K992221. K000051, K001519 and K002466); 2. Brennen Medical, Inc. Glucan 11 Wound Dressing (K964241). The predica… | 1998 |
| * | K992221 | Acticoat Primary Antimicrobial DressingSummary page 2…tain silver or glucan and have been reviewed by ODE and found substantially equivalent The predicate devices are: I. Acticoat Silver Coated Dressing (K983833. K992221. K000051, K001519 and K002466); 2. Brennen Medical, Inc. Glucan 11 Wound Dressing (K964241). The predicate device… | 2000 |
| * | K000051 | Acticoat Foam DressingSummary page 2…glucan and have been reviewed by ODE and found substantially equivalent The predicate devices are: I. Acticoat Silver Coated Dressing (K983833. K992221. K000051, K001519 and K002466); 2. Brennen Medical, Inc. Glucan 11 Wound Dressing (K964241). The predicate devices are all ster… | 2000 |
| * | K001519 | Acticoat 7 DressingSummary page 2…nd have been reviewed by ODE and found substantially equivalent The predicate devices are: I. Acticoat Silver Coated Dressing (K983833. K992221. K000051, K001519 and K002466); 2. Brennen Medical, Inc. Glucan 11 Wound Dressing (K964241). The predicate devices are all sterile, sing… | 2000 |
| * | K002466 | Acticoat Composite DressingSummary page 2…reviewed by ODE and found substantially equivalent The predicate devices are: I. Acticoat Silver Coated Dressing (K983833. K992221. K000051, K001519 and K002466); 2. Brennen Medical, Inc. Glucan 11 Wound Dressing (K964241). The predicate devices are all sterile, single use cover… | 2001 |
| * | K964241 | Brennen Medical Glucan II Wound DressingSummary page 2…predicate devices are: I. Acticoat Silver Coated Dressing (K983833. K992221. K000051, K001519 and K002466); 2. Brennen Medical, Inc. Glucan 11 Wound Dressing (K964241). The predicate devices are all sterile, single use coverings for wounds. Each of the silver predicate devices, as wel… | 1996 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 6 other devices also cite its predicate K955453.
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?
Silver Glucan Wound Dressing ts an effective barrier 1o bacterial and candida penerration. The dressing, may be used for partial and full thickness wounds including decubitus ulcers. venous stasis ulcers, diabetic uleers. tirst and sccond degree buns, donor sites. and surgical wounds. Silver Glucan dressings miv be used over partial thickness wounds. debrided wounds. and as a temporary covering fur full (hickness and erafled wounds.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050086: Brennen Medical Silver Glucan 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/K050086
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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