510(k) · Cleared
ClearedSilveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andover Healthcare, Inc. · FRO Dressing, Wound, Drug
Cleared on Oct 30, 2009 as substantially equivalent to K050649 (Noble Fiber Technologies, Inc., 2005) and 3 other predicates after a 372-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.
- Decided
- Oct 30, 2009
- Review
- 372 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K914579 (1992). 15 ancestors in all, the oldest K890354 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 2 generations backK033587 SilversealNoble Fiber Technologies · 2004
- 1 generation backK050649 Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
- This deviceK083133 Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing…Andover Healthcare, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK242856 LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON®…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK223359 LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2024 · cites it directly1descendant
- K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024 · 2 generations on0descendants
- K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −2 | K033587 | Silverseal | Noble Fiber Technologies | 2004 | — |
| −1 | K050649 | Silverseal Contacting Wound Dressing with X-Static | Noble Fiber Technologies, Inc. | 2005 | — |
| 0 (this device) | K083133 | Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex… | Andover Healthcare, Inc. | 2009 | — |
| +1 | K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +2 | K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +1 | K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K050649 | Silverseal Contacting Wound Dressing with X-StaticSummary page 3…gs are substantially equivalent in design, function and intended use to several legally marketed wound dressings including: SILVERSEAL® Contact wound dressing (K050649) (Noble Fiber Technology), Acticoat Moisture Control Dressing® (K050030) (Smith and Nephew), Mepilex Ag® Silicone-Coate… | 2005 |
| * | K050030 | Acticoat Moisture Control DressingSummary page 1…sings Classification Name: Dressings 3. PREDICATE DEVICES *SILVERSEALS Contact wound dressing (KO5 0649) *Acticoat Moisture Control Dressingg (K050030) *Mepilex Agg Silicone-Coated Dressing (K061554) *Polymemg Silver Wound Dressing (KO3 1307) 4. DEVICE DESCRIPTION… | 2005 |
| * | K061554 | Mepilex AG Absorbent Silicone-Coated DressingSummary page 1…PREDICATE DEVICES *SILVERSEALS Contact wound dressing (KO5 0649) *Acticoat Moisture Control Dressingg (K050030) *Mepilex Agg Silicone-Coated Dressing (K061554) *Polymemg Silver Wound Dressing (KO3 1307) 4. DEVICE DESCRIPTION The Andover Healthcare, Inc. X AFD Dressings ar… | 2007 |
| * | K031307 | Ferris Polymem Silver Wound DressingSummary page 3…ture Control Dressing® (K050030) (Smith and Nephew), Mepilex Ag® Silicone-Coated Dressing (K061554) (M6lnlycke Health Care) and Polymem® Silver Wound Dressing (K031307) (Ferris Manufacturing). All of the Andover Healthcare, Inc. X AFD contact wound dressings and all of the predicate de… | 2003 |
What descends from it? (3)
2 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 17 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K223360 (Huizhou Foryou Medical Devices Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K050649.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Under the supervision of a health care professional, CoFlex - X AFD® and the CoFlex - X AFD® Pad contact wound dressings are indicated for use in light to heavy exuding partial and full thickness wounds, including decubitus and diabetic ulcers, 1st and 2nd degree burns, and donor sites. These dressings may also be used over debrided and partial thickness wounds.
For over the-counter use, PowerFlex NL - X AFD® and CoFlex - X AFD® First Aid contact wound dressings are, indicated for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083133: Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083133
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