510(k) · Cleared
ClearedAquacel Hydrofiber Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, A Bristol-Myers Squibb Co. · KMF Bandage, Liquid
Cleared on Sep 8, 1998 after an 84-day review. The FDA summary names its predicate without a number. 60 later devices descend from it.
- Decided
- Sep 8, 1998
- Review
- 84 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 3 citing it directly.
- This deviceK982116 Aquacel Hydrofiber Wound DressingConvatec, A Bristol-Myers Squibb Co. · 1998
- Descendant · cites it directly · 54 of its ownK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- Descendant · 2 generations on · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
- Descendant · 2 generations on · 13 of its ownK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK070175 Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007
- Descendant · 3 generations on · 5 of its ownK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008 · cites it directly54descendants
- K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · 2 generations on13descendants
- K121275Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberConvatec, Inc. · 2012 · 2 generations on13descendants
- K070175Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd. · 2007 · cites it directly6descendants
- K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982116 | Aquacel Hydrofiber Wound Dressing | Convatec, A Bristol-Myers Squibb Co. | 1998 | — |
| +1 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| +2 | K122817 | Silverlon Island Wound Dressing | Argentum Medical, LLC | 2014 | — |
| +2 | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber | Convatec, Inc. | 2012 | — |
| +1 | K070175 | Aquanova Super-Absorbent Gelling Dressing, Otc | Medtrade Products, Ltd. | 2007 | — |
| +3 | K143001 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing | Argentum Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 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 KMF? 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 KMF device
- #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | Kaltostat® Wound Dressing Named without a submission number |
What descends from it? (60)
See all 603 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?
- Of its descendants, K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) has gone furthest, with 54 descendants of its own.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 2025
MAUDE reports naming product code KMF, 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 | 2 | — | 1 | 6 |
| 2008 | 3 | 35 | 0 | 2 |
| 2009 | 3 | 213 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For Over The Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, lacerations, minor cuts and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for wounds such as: leg ulcers, pressure ulcers (Stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree); management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic 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/K982116 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982116: Aquacel Hydrofiber 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/K982116
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