510(k) Report

510(k) · Cleared

Cleared

Exsept WC Wound Cleanser

K061467510(k) TraditionalCleared Feb 15, 2007265-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alcavis International, Inc. · FRO Dressing, Wound, Drug

Cleared on Feb 15, 2007 as substantially equivalent to K965120 (Dpt Laboratories, Ltd., 1997) and 2 other predicates after a 265-day review. Its family tree reaches back 4 generations to 1995. 11 later devices descend from it.

Decided
Feb 15, 2007
Review
265 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K945802 (1995). 5 ancestors in all. 11 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2011: 1 descendant cleared2009: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant cleared2025: 2 descendants cleared2026: 2 descendants cleared2023: 1 descendant cleared2017: 1 descendant clearedK945802 · Dermagran Wound Cleanser with Zinc · Derma Sciences, Inc. · 1995K965120 · Allclenz Wound Cleanser · Dpt Laboratories, Ltd. · 1997K022670 · Carraklenz and Ultraklenz · Carrington Laboratories, Inc. · 2002K042729 · Dermacyn Wound Irrigation · Oculus Innovative Sciences, Inc. · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K042729 · Dermacyn Wound Irrigation · Oculus Innovative Sciences, Inc. · 2005K022670 · Carraklenz and Ultraklenz · Carrington Laboratories, Inc. · 2002K965120 · Allclenz Wound Cleanser · Dpt Laboratories, Ltd. · 1997K945802 · Dermagran Wound Cleanser with Zinc · Derma Sciences, Inc. · 19950+5
  1. Root · 4 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
  2. 3 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
  3. 2 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
  4. 1 generation backK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
  5. This deviceK061467 Exsept WC Wound CleanserAlcavis International, Inc. · 2007
  6. Descendant · cites it directly · 9 of its ownK111313 Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC · 2011
  7. Descendant · 2 generations on · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
  8. Descendant · 3 generations on · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
  9. Descendant · 3 generations on · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
  10. Descendant · 3 generations on · 1 of its ownK243415 Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12014: 22016: 12017: 12023: 12025: 22026: 2
2009high 2 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all
  • K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC · 2011 · cites it directly9descendants
  • K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014 · 2 generations on8descendants
  • K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 3 generations on4descendants
  • K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 3 generations on3descendants
  • K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K945802Dermagran Wound Cleanser with ZincDerma Sciences, Inc.1995—
−3K965120Allclenz Wound CleanserDpt Laboratories, Ltd.1997—
−2K022670Carraklenz and UltraklenzCarrington Laboratories, Inc.2002—
−1K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc.2005—
0 (this device)K061467Exsept WC Wound CleanserAlcavis International, Inc.2007—
+1K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC2011—
+2K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.2014—
+3K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences2014—
+3K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences2016—
+3K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201420
201610
201710
202310
202520
202620
FIG. 1 — Lineage of K061467, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FRO? 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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K965120Allclenz Wound Cleanser
Summary page 1
…Common Name: Wound Cleanser Classification Name: Liquid Bandage (21CFR 880.5090) Predicate Devices: Allclenz Wound Cleaner, K965120 CarraKlenz Wound Cleanser, K022670 Dermacyn Wound Cleanser, K042729 Device Description: ExS…
Dpt Laboratories, Ltd.1997—
*K022670Carraklenz and Ultraklenz
Summary page 1
…Classification Name: Liquid Bandage (21CFR 880.5090) Predicate Devices: Allclenz Wound Cleaner, K965120 CarraKlenz Wound Cleanser, K022670 Dermacyn Wound Cleanser, K042729 Device Description: ExSept WC is a clear to slight yellow, slight chlorine od…
Carrington Laboratories, Inc.2002—
*K042729Dermacyn Wound Irrigation
Summary page 1
…age (21CFR 880.5090) Predicate Devices: Allclenz Wound Cleaner, K965120 CarraKlenz Wound Cleanser, K022670 Dermacyn Wound Cleanser, K042729 Device Description: ExSept WC is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical…
Oculus Innovative Sciences, Inc.2005—

Also cleared against K965120: 7 other devices →

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119
K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090

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?

  • The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K111313 (Alcavis Hdc, LLC, 2011) has gone furthest, with 9 descendants of its own.
  • 7 other devices also cite its predicate K965120.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

For debridement and the removal of foreign material and debris from

exudating and/or dirty wounds, abrasions and minor irritations, cuts, exit sites,

and intact skin.

Indications for use as stated in the FDA summary.

Also cleared against K965120

7 other devices cite the same predicate.

  • K143444SynePure Wound CleanserSynedgen, Inc. · 2015
  • K092232Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc. · 2009
  • K060901Vashe Wound Cleansing SystemSterilox Technologies, Inc. · 2006
  • K060113Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
  • K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
  • K040779Restore Wound CleanserHollister, Inc. · 2004

More from Alcavis International, Inc.

3 FDA decisions under this applicant name. See the company

  • K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc. · 2009
  • K043126Assist Header CleanerAlcavis International, Inc. · 2005

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K061467 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061467: Exsept WC Wound Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061467

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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