510(k) · Cleared
ClearedDermagran Wound Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Derma Sciences, Inc. · KMF Bandage, Liquid
Cleared on Aug 12, 1997 as substantially equivalent to K945802 (Derma Sciences, Inc., 1995) and 4 other predicates after a 172-day review. Its family tree reaches back 1 generation to 1994. 12 later devices descend from it.
- Decided
- Aug 12, 1997
- Review
- 172 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K944491 (1994). 5 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK944491 Dermagran Hydrophilic OintmentDerma Sciences, Inc. · 1994
- This deviceK970660 Dermagran Wound Management SystemDerma Sciences, Inc. · 1997
- Descendant · cites it directly · 9 of its ownK080779 Irrisept Wound Cleansing SystemIrrimax Corporation · 2009 · Recalled
- Descendant · 2 generations on · 7 of its ownK202222 Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020
- Descendant · 3 generations on · 6 of its ownK210536 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021
- Descendant · 2 generations on · 4 of its ownK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- Descendant · 3 generations on · 3 of its ownK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K080779Irrisept Wound Cleansing SystemIrrimax Corporation · 2009 · cites it directly9descendants
- K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020 · 2 generations on7descendants
- K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021 · 3 generations on6descendants
- K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020 · 2 generations on4descendants
- K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944491 | Dermagran Hydrophilic Ointment | Derma Sciences, Inc. | 1994 | — |
| 0 (this device) | K970660 | Dermagran Wound Management System | Derma Sciences, Inc. | 1997 | — |
| +1 | K080779 | Irrisept Wound Cleansing System | Irrimax Corporation | 2009 | 2 |
| +2 | K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020 | — |
| +3 | K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021 | — |
| +2 | K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020 | — |
| +3 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K945802 | Dermagran Wound Cleanser with ZincSummary page 1…Date Summary Prepared: February 4, 1997 Name of the Device: Dermagran Wound Management System ‘ Identification of Predicate Devices: Dermagran Wound Cleanser with Zinc: K945802 and j K954743 ‘ i ) Dermagran-B Hydrophilic Wound Ointment: K944491, 1 © K954739 and K963603 j Description of the Device: Derm… | 1995 |
| * | K954743 | Dermagran Wound Dressing Cleaner W/ZincSummary page 1…repared: February 4, 1997 Name of the Device: Dermagran Wound Management System ‘ Identification of Predicate Devices: Dermagran Wound Cleanser with Zinc: K945802 and j K954743 ‘ i ) Dermagran-B Hydrophilic Wound Ointment: K944491, 1 © K954739 and K963603 j Description of the Device: Dermagran Wound Ma… | 1995 |
| * | K944491 | Dermagran Hydrophilic OintmentSummary page 1…Wound Management System ‘ Identification of Predicate Devices: Dermagran Wound Cleanser with Zinc: K945802 and j K954743 ‘ i ) Dermagran-B Hydrophilic Wound Ointment: K944491, 1 © K954739 and K963603 j Description of the Device: Dermagran Wound Management System (System) contains two components, Derma… | 1994 |
| * | K954739 | Dermagran Hydrophilic OintmentSummary page 1…ment System ‘ Identification of Predicate Devices: Dermagran Wound Cleanser with Zinc: K945802 and j K954743 ‘ i ) Dermagran-B Hydrophilic Wound Ointment: K944491, 1 © K954739 and K963603 j Description of the Device: Dermagran Wound Management System (System) contains two components, Dermagran Wound Cl… | 1995 |
| * | K963603 | Dermagran Hydrophilic OintmentSummary page 1…‘ Identification of Predicate Devices: Dermagran Wound Cleanser with Zinc: K945802 and j K954743 ‘ i ) Dermagran-B Hydrophilic Wound Ointment: K944491, 1 © K954739 and K963603 j Description of the Device: Dermagran Wound Management System (System) contains two components, Dermagran Wound Cleanser with… | 1996 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
Dermagran® Wound Management System (Systerm), when applied to the wound provides a wound cleanser and primary cover and/or filler for wound deficiencies. The System absorbs exudate and creates a moist, mildly acidic wound environment. The moist environment created by the System s conducive to wound healing and autolytic debridement.
The System is useful in the management of various skin injuries which result in lacerations, abrasions. post-surgical wounds, skin ulcerations (pressure, diabetic, venous stasis), surgical incisions, and partial thickness burns.
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/K970660 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970660: Dermagran Wound Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970660
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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