510(k) · Cleared
ClearedLyofoam Extra 'A' Sterile Adhesive Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acme United Corp. · KMF Bandage, Liquid
Cleared on May 31, 1996 as substantially equivalent to K895764 (Acme United Corp., 1990) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 31, 1996
- Review
- 45 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895764 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895764 Modified Lyofoam Wound DressingsAcme United Corp. · 1990
- This deviceK961452 Lyofoam Extra 'A' Sterile Adhesive Wound DressingAcme United Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895764 | Modified Lyofoam Wound Dressings | Acme United Corp. | 1990 | — |
| 0 (this device) | K961452 | Lyofoam Extra 'A' Sterile Adhesive Wound Dressing | Acme United Corp. | 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 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? (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 |
|---|---|---|---|
| * | K895764 | Modified Lyofoam Wound DressingsSummary page 3…und in the Lyofoam@ Extra 510(K) File K952565. Safety: Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Modified Lyofoam® Dressing file; K895764. All safety data is summarized in those files and indicates product is safe for use. Sterility and Packaging: Lyofoam® Extra "A… | 1990 |
| * | K952565 | Lyofoam ExtraSummary page 3…one (203) 332-7330 _ Page 14 K6iysa Acme United Corporation pfl-@& 3.4 3 Performance data for this product can be found in the Lyofoam@ Extra 510(K) File K952565. Safety: Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Modified Lyofoam® Dressing file; K8957… | 1995 |
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 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?
The Lyofoam® Extra "A" Sterile Adhesive Wound Dressing is intended for the treatment of moderately to heavily exuding 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/K961452 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961452: Lyofoam Extra 'A' Sterile Adhesive Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961452
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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