510(k) · Cleared
ClearedDermaphylyx Hydrophilic Foam Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermaphylyx, Inc. · KMF Bandage, Liquid
Cleared on Aug 12, 1999 after a 66-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 12, 1999
- Review
- 66 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK991920 Dermaphylyx Hydrophilic Foam Wound DressingDermaphylyx, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK131384 Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage…Kericure, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK182733 Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK171148 Aleo BME Liquid BandageAleo Bme, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K131384Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKericure, Inc. · 2014 · cites it directly2descendants
- K182733Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019 · 2 generations on0descendants
- K171148Aleo BME Liquid BandageAleo Bme, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991920 | Dermaphylyx Hydrophilic Foam Wound Dressing | Dermaphylyx, Inc. | 1999 | — |
| +1 | K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage | Kericure, Inc. | 2014 | — |
| +2 | K182733 | Rochal Bioshield Silicone Film | Rochal Industries, LLC | 2019 | — |
| +2 | K171148 | Aleo BME Liquid Bandage | Aleo Bme, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | — | Spyrofoam® Wound Dressings (Innovative Technologies US, Inc.) Named without a submission number | |
| * | — | Hydrasorb® Sterile Dressings (ConvaTec/Calgon Vestal Laboratories) Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage | 2014 | 2 |
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, K131384 (Kericure, Inc., 2014) has gone furthest, with 2 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 | — |
What is it indicated for?
Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They are intended for use in the management of partial and full-thickness wounds. The following indications for use are for Prescription Use or under the direction of a health care professional: Venous stasis ulcers Burns, (superficial) Diabetic ulcers Abrasions and lacerations Pressure sores Incisions Donor sites Additionally Fenestrated dressings are…
Read the full statement (104 words)
Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They are intended for use in the management of partial and full-thickness wounds.
The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers Burns, (superficial)
Diabetic ulcers Abrasions and lacerations
Pressure sores Incisions
Donor sites
Additionally Fenestrated dressings are intended for use in the management of surgically induced drainage sites such as:
G-tubes, J-tubes, Penrose drains, chest tubes, nephrotomy tubes, and sump drains.
The following indications for use are for Over-the-Counter Use:
Minor Burns
Minor cuts
Minor abrasions
Minor lacerations
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/K991920 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991920: Dermaphylyx Hydrophilic Foam 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/K991920
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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