510(k) · Cleared
ClearedAllevyn Hydro Poly Dressing ND All Trac Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew United, Inc. · KMF Bandage, Liquid
Cleared on Oct 25, 1996 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 25, 1996
- Review
- 77 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK963096 Allevyn Hydro Poly Dressing ND All Trac DressingSmith & Nephew United, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK063835 Allevyn AG DressingSmith & Nephew, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK110062 Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AGMedipurpose Pte., Ltd. · 2011
- Descendant · 3 generations on · 0 of its ownK141619 Luofucon Silver Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK121361 Curaline Polyurethane Foam Awc DressingCuraline, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK091013 Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited · 2009
Most influential descendants
Showing 5 of 5 · See all- K063835Allevyn AG DressingSmith & Nephew, Inc. · 2007 · cites it directly3descendants
- K110062Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AGMedipurpose Pte., Ltd. · 2011 · 2 generations on1descendant
- K141619Luofucon Silver Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · 3 generations on0descendants
- K121361Curaline Polyurethane Foam Awc DressingCuraline, Inc. · 2012 · cites it directly0descendants
- K091013Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963096 | Allevyn Hydro Poly Dressing ND All Trac Dressing | Smith & Nephew United, Inc. | 1996 | — |
| +1 | K063835 | Allevyn AG Dressing | Smith & Nephew, Inc. | 2007 | — |
| +2 | K110062 | Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AG | Medipurpose Pte., Ltd. | 2011 | — |
| +3 | K141619 | Luofucon Silver Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2015 | — |
| +1 | K121361 | Curaline Polyurethane Foam Awc Dressing | Curaline, Inc. | 2012 | — |
| +2 | K091013 | Silver PU Antibacterial Foam Dressing - Non Adherent and Island | Advanced Medical Solutions Limited | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K063835 (Smith & Nephew, Inc., 2007) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K963096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963096: Allevyn Hydro Poly Dressing ND All Trac Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963096
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026