510(k) · Cleared
ClearedExufiber Ag+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molnlycke Health Care Us, LLC · FRO Dressing, Wound, Drug
Cleared on Aug 25, 2016 as substantially equivalent to K121275 (Convatec, Inc., 2012) after a 197-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Aug 25, 2016
- Review
- 197 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914604 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 4 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 3 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 2 generations backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- 1 generation backK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012
- This deviceK160379 Exufiber Ag+Molnlycke Health Care Us, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −4 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −3 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −2 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| −1 | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber | Convatec, Inc. | 2012 | — |
| 0 (this device) | K160379 | Exufiber Ag+ | Molnlycke Health Care Us, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberSummary page 4…FRO Predicate Device Name(s): Aquacel Ag Extra Hydrofiber Dressing with Silver and Strengthening Fiber (K121275) Description of Device: Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a highly absorbent and gel-forming wound dressing t… | 2012 |
| † | K122634 | Iodofoam Iodophor Foam Dressing | 2013 |
| † | K123892 | Mepilex Transfer AG | 2013 |
| † | K130040 | Mepitel AG | 2014 |
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 24 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 ancestors has a recall.
- 5 other devices also cite its predicate K121275.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 over-the-counter use, Exufiber Ag+ may be used for: • Abrasions • Lacerations • Minor cuts • Minor scalds and burns Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds: • Leg ulcers (venous stasis ulcers, arterial ulcers and ulcers of mixed etiology) and diabetic foot ulcers • Pressure ulcers (partial and full thickness) • Partial thickness burns • Donor sites and…
Read the full statement (175 words)
For over-the-counter use, Exufiber Ag+ may be used for:
• Abrasions
• Lacerations
• Minor cuts
• Minor scalds and burns
Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:
• Leg ulcers (venous stasis ulcers, arterial ulcers and ulcers of mixed etiology) and diabetic foot ulcers
• Pressure ulcers (partial and full thickness)
• Partial thickness burns
• Donor sites and other wounds that are prone to bleeding, such as debrided wounds
• Traumatic wounds
• Surgical wounds that heal by primary intention, such as dermatological and surgical incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions
• Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi’s sarcoma and angiosarcoma
Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.
Indicated wear time: up to seven (7) days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160379: Exufiber Ag+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160379
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