510(k) · Cleared
ClearedSilverlon Wound Packing Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argentum International, LLC · FRO Dressing, Wound, Drug
Cleared on Sep 24, 1999 as substantially equivalent to K981299 (Argentum International, LLC, 1998) after a 304-day review. Its family tree reaches back 3 generations to 1992. 25 later devices descend from it.
- Decided
- Sep 24, 1999
- Review
- 304 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914579 (1992). 5 ancestors in all, the oldest K890354 (1989). 25 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 backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- This deviceK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- Descendant · cites it directly · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- Descendant · 2 generations on · 11 of its ownK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- Descendant · cites it directly · 9 of its ownK033587 SilversealNoble Fiber Technologies · 2004
- Descendant · 3 generations on · 5 of its ownK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
- Descendant · 2 generations on · 5 of its ownK050649 Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · cites it directly17descendants
- K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 2010 · 2 generations on11descendants
- K033587SilversealNoble Fiber Technologies · 2004 · cites it directly9descendants
- K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · 3 generations on5descendants
- K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005 · 2 generations on5descendants
View 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 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| 0 (this device) | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| +1 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| +2 | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | Coloplast A/S | 2010 | — |
| +1 | K033587 | Silverseal | Noble Fiber Technologies | 2004 | — |
| +3 | K140954 | Luofucon Silver PU Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2015 | — |
| +2 | K050649 | Silverseal Contacting Wound Dressing with X-Static | Noble Fiber Technologies, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K981299 | Silverlon Contact Wound DressingSummary page 1…e is being claimed Silverlon™ Wound Packing Strips are substantially equivalent in function and intended use to: Argentum Research’s Silverlon™ Contact Wound Dressing (K981299) and Johnson and Johnson’s Nu Gauze Packing Strips (pre-amendment device). 10.1.4 Device Description 26 Sep-22… | 1998 |
| * | — | Nu Gauze Packing Strips Named without a submission number |
What descends from it? (25)
See all 253 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 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K033869 (Coloplast Corp., 2004) has gone furthest, with 17 descendants of its own.
- 12 other devices also cite its predicate K981299.
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?
Silverlon™ Wound Packing Strips are sterile, non-adherent, silver wound dressings.
The Prescription Professional indications:
Control of local wound bleeding and nasal hemorrhage, to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a “wet-to-dry” packing.
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/K984210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984210: Silverlon Wound Packing Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984210
Report an extraction error
Are you the manufacturer?
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