510(k) · Cleared
ClearedModification of:Bioderm Foam Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioderm, Inc. · KMF Bandage, Liquid
Cleared on May 18, 1999 after a 57-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- May 18, 1999
- Review
- 57 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K976230 | Hytirasorb Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…1999 @@ Device Trade Name: Bioderm Foam Wound Dressing Device Common Namae: Wound Dressing Classification Name: 79 FRO Dressing (8)(3) 4 Predicate Device: Hytirasorb (K976230) (a) (4) Device Description: The device has not changed from those approved under Bioderm, inc. K382778 and consist of square,… |
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.
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 Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist healing environment, manage exudate, and protect the wound from contamination. The dressing is indicated for the management of the following types of wounds: Partial and full-thickness wounds, moderate to heavily exudating wounds such as; lower extremity ulcers including; venous stasis ulcers, arterial ulcers, or mixed etiology (venous & arterial) and post…
Read the full statement (115 words)
The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist healing environment, manage exudate, and protect the wound from contamination. The dressing is indicated for the management of the following types of wounds:
Partial and full-thickness wounds, moderate to heavily exudating wounds such as; lower extremity ulcers including; venous stasis ulcers, arterial ulcers, or mixed etiology (venous & arterial) and post surgical incisions, pressure sores, and diabetic foot ulcers.
Partial thickness wounds such as; donor sites, abrasions, lacerations, and superficial burns.
Other indications include a drainage dressing for tracheostomy, G-tube, J-tube, Penrose drain, chest tube, or sump drain, as well as a secondary or cover dressing for packed 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/K990955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990955: Modification of:Bioderm Foam 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/K990955
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)
- Page last updated Nov 3, 2026