510(k) · Cleared
ClearedAlldress Multi Layered Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molnlycke/Scott Health Care · NAD Dressing, Wound, Occlusive
Cleared on Mar 13, 1996 as substantially equivalent to K945206 (Scott Health Care, 1995) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 13, 1996
- Review
- 77 days
- Class
- Class I
- Product code
- NAD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941263 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK941263 Comfeel Plus Wound DressingRichard Hamer Assoc., Inc. · 1994
- This deviceK955863 Alldress Multi Layered Wound DressingMolnlycke/Scott Health Care · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941263 | Comfeel Plus Wound Dressing | Richard Hamer Assoc., Inc. | 1994 | — |
| 0 (this device) | K955863 | Alldress Multi Layered Wound Dressing | Molnlycke/Scott Health Care | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 NAD? 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 NAD device
- #1 K254246 LT Antibacterial Foam with Silver Dressingscore 13.5 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K945206 | Alldress Multi Layered Wound DressingSummary page 1…d Dressing Wound Dressing | Regulatory Class: Unclassified \ Product Code: 79FRO ‘1 1 iil. PREDICATE DEVICE | AllDress® Multi Layered Wound Dressing (Scott Health Care; K945206) ;I' [ V. DEVICE DESCRIPTION The AllDress® Multi Layered Wound Dressing is a sterile wound dressing com- posed of an absorbent… | 1995 |
| * | K941263 | Comfeel Plus Wound DressingSummary page 1…AllDress” Multi Layered Wound Dressing (K945206) and is identical to the predicate device with respect to function and intended use. to the Comfeel® Plus Ulcer Dressing (K941263). The composition of the backing layer of the modified product has been changed to improve the wound barrier prop- erties of the… | 1994 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All NAD devicesNAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAD
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NAD
Too few NAD 510(k)s in any year since 2007 to give a median.
Recalls per year · NAD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAD
2,619in 2025
MAUDE reports naming product code NAD, 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 | 0 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 1 | 30 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 1 | 63 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 0 | — | 0 | 106 |
| 2017 | 0 | — | 0 | 134 |
| 2018 | 0 | — | 6 | 1,029 |
| 2019 | 0 | — | 0 | 588 |
| 2020 | 0 | — | 0 | 5,035 |
| 2021 | 0 | — | 0 | 451 |
| 2022 | 0 | — | 1 | 403 |
| 2023 | 0 | — | 0 | 1,619 |
| 2024 | 0 | — | 0 | 1,804 |
| 2025 | 0 | — | 1 | 2,619 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For the dressing and management of chronic/open 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/K955863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955863: Alldress Multi Layered Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955863
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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