510(k) · Cleared
ClearedCarraklenz and Ultraklenz
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carrington Laboratories, Inc. · FRO Dressing, Wound, Drug
Cleared on Oct 17, 2002 as substantially equivalent to K965120 (Dpt Laboratories, Ltd., 1997) and 2 other predicates after a 66-day review. Its family tree reaches back 2 generations to 1995. 1 of the 109 devices in its family, counting itself, has a Class I recall. 105 later devices descend from it.
- Decided
- Oct 17, 2002
- Review
- 66 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945802 (1995). 3 ancestors in all. 105 later devices descend from it, 9 citing it directly. 1 of the 109 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 1 generation backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- This deviceK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- Descendant · cites it directly · 89 of its ownK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
Showing 5 of 105 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 105 · See all- K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005 · cites it directly89descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · cites it directly73descendants
- 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
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 3 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −1 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| 0 (this device) | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| +1 | K042729 | Dermacyn Wound Irrigation | Oculus Innovative Sciences, Inc. | 2005 | — |
| +1 | 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 | — |
| +3 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 5 | 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K965120 | Allclenz Wound CleanserSummary page 2…LENCE TECHNOLOGICAL The Carrington Laboratories Wound Cleansers are substantially equivalent LO the Allclenz Wound Cleamcr cleared for inwketing under K965 120 and the Dema Sciences Dennagran Wound Cleanser with Zinc cleared under €354743 and K945802. All of the wom~dcleansers… | 1997 |
| * | K954743 | Dermagran Wound Dressing Cleaner W/Zinc Our reading of the summary gave K354743, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Derma Sciences Dermagran Wound Cleanser with Zinc”. | 1995 |
| * | K945802 | Dermagran Wound Cleanser with ZincSummary page 1…3. PREDICATE DEVKRS Alfcleiiz Wound Cleanser K9GS I 21) Denna Sciences Dtrmagran Wound Cluascr with Zinc $354743 and K945802 ?lie Carrington CmrirKlenz Wound Cleansers are wound cleaning solutions that are intended €or the cleansing and ir… | 1995 |
What descends from it? (105)
See all 1059 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042729 | Dermacyn Wound Irrigation | 2005 | 89 |
| K063069 | Silvaklenz Skin and Wound Clenser Solution | 2007 | 73 |
| K060113 | Dermacyn Wound Care | 2006 | 52 |
| K040779 | Restore Wound Cleanser | 2004 | 28 |
| K092232 | Modification to:Vashe Wound Cleansing System, Model 9000-0014 | 2009 | 16 |
| K063063 | Silvacide Skin & Wound Moisturizing Solution | 2007 | 14 |
| K061467 | Exsept WC Wound Cleanser | 2007 | 11 |
| K080779 | Irrisept Wound Cleansing System | 2009 | 9 |
| 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042729 (Oculus Innovative Sciences, Inc., 2005) has gone furthest, with 89 descendants of its own.
- 7 other devices also cite its predicate K965120.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
The Carrington Wound Cleansers are surfactant wound cleansers intended for the removal of foreign material such as dirt and debris from dermal wounds.
CarraKlenz is a wound cleanser that is indicated for high, medium, and low exudating wounds.
UltraKlenz is a gentle wound cleanser which is used on intact 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/K022670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022670: Carraklenz and Ultraklenz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022670
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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