510(k) · Cleared
ClearedLyofoam Extra C Odor Absorbing 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 Jun 19, 1996 as substantially equivalent to K864084 (Acme United Corp., 1986) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jun 19, 1996
- Review
- 75 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864084 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864084 Lyofoam C Odor-Absorbing DressingAcme United Corp. · 1986
- This deviceK961323 Lyofoam Extra C Odor Absorbing Wound DressingAcme United Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864084 | Lyofoam C Odor-Absorbing Dressing | Acme United Corp. | 1986 | — |
| 0 (this device) | K961323 | Lyofoam Extra C Odor Absorbing 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 |
|---|---|---|---|
| * | K864084 | Lyofoam C Odor-Absorbing DressingSummary page 3…Page 14 Acme United Corporation Safety test data can be found in both the Lyofoam® Extra 510(K) file K952565 and Lyofoam® "C"Odor Absorbing Wound Dressing 510(K) file; K864084. All safety data is summarized in those files and indicates product is safe for use. Lyofoam® Extfa "C" Odor Absorbing Wound Dr… | 1986 |
| * | K952565 | Lyofoam ExtraSummary page 2…ed to treat lightly to moderately exuding wounds. Perfcrmance date for the Lyofoam® Extra dressing segment of this product an be found in the Lyofoam® Extra 510(K) file K952565. 75 Kings Highway Cutoff * Fairfield, CT 06430 « Phone: (203) 332-7330 « Fax: (203) 576-0022 Safety: Sterility… | 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 "C" Odor Absorbing 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/K961323 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961323: Lyofoam Extra C Odor Absorbing 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/K961323
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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