510(k) · Cleared
ClearedAllclenz Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dpt Laboratories, Ltd. · KMF Bandage, Liquid
Cleared on Mar 21, 1997 as substantially equivalent to K945802 (Derma Sciences, Inc., 1995) after an 88-day review. Its family tree reaches back 1 generation to 1995. 1 of the 109 devices in its family, counting itself, has a Class I recall. 107 later devices descend from it.
- Decided
- Mar 21, 1997
- Review
- 88 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945802 (1995). 107 later devices descend from it, 8 citing it directly. 1 of the 109 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- This deviceK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- Descendant · cites it directly · 105 of its ownK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- Descendant · cites it directly · 89 of its ownK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
- Descendant · 2 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 2 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · cites it directly · 52 of its ownK060113 Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
Showing 5 of 107 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K083042 Wound Flush, Sterile Water & Normal Saline2 generations on · 2008
Most influential descendants
Showing 5 of 107 · See all- K022670Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002 · cites it directly105descendants
- K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005 · cites it directly89descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 2 generations on73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 2 generations on66descendants
- K060113Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006 · cites it directly52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| 0 (this device) | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| +1 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| +1 | K042729 | Dermacyn Wound Irrigation | Oculus Innovative Sciences, Inc. | 2005 | — |
| +2 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +2 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +1 | K060113 | Dermacyn Wound Care | Oculus Innovative Sciences, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 1 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 11 | 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.
1 device in this family has a Class I recall. 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945802 | Dermagran Wound Cleanser with ZincSummary page 1…Aliclenz™™ Wound Cleanser Common Name: Wound Cleanser Classification Name: Liquid bandage . PREDICATE DEVICE Dermagran Wound Cleanser with Zinc; Derma Sciences, Inc.; K945802: 2/27/95. DEVICE DESCRIPTION The Aliclenz'* Wound Cleanser is a colorless, transfiare_nt solution supplied non- sterile in 12 fl… | 1995 |
What descends from it? (107)
See all 1078 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022670 | Carraklenz and Ultraklenz | 2002 | 105 |
| K042729 | Dermacyn Wound Irrigation | 2005 | 89 |
| K060113 | Dermacyn Wound Care | 2006 | 52 |
| K040779 | Restore Wound Cleanser | 2004 | 28 |
| K092232 | Modification to:Vashe Wound Cleansing System, Model 9000-0014 | 2009 | 16 |
| K061467 | Exsept WC Wound Cleanser | 2007 | 11 |
| K143444 | SynePure Wound Cleanser | 2015 | 0 |
| K060901 | Vashe Wound Cleansing System | 2006 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
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?
For the cleansing of dermal lesions such as stage I-V pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritation of the skin.
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/K965120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965120: Allclenz Wound Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965120
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026