510(k) Report

510(k) · Cleared

Cleared

Exsept WC Antimicrobial Skin and Wound Cleanser

K082858510(k) TraditionalCleared May 27, 2009240-day reviewClass II21 CFR 880.5475

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

Alcavis International, Inc. · FQH Lavage, Jet

Cleared on May 27, 2009 as substantially equivalent to K061467 (Alcavis International, Inc., 2007) and 3 other predicates after a 240-day review. Its family tree reaches back 6 generations to 1992.

Decided
May 27, 2009
Review
240 days
Class
Class II
Product code
FQH
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K914579 (1992). 27 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2005: 1 other ancestor2006: 1 other ancestor2004: 1 other ancestor2002: 2 other ancestors2001: 3 other ancestors1997: 3 other ancestors1999: 2 other ancestors1998: 2 other ancestors1995: 2 other ancestors1993: 1 other ancestor1989: 2 other ancestorsK914579 · Silver Foam Wound Dressing · Vitaphore Corp. · 1992K955453 · Acticoat Silver Coated Dressing · Westaim Technologies, Inc. · 1996K981299 · Silverlon Contact Wound Dressing · Argentum International, LLC · 1998K023612 · Silverlon Contact Wound Dressing · Argentum International, LLC · 2003K063069 · Silvaklenz Skin and Wound Clenser Solution · Medical Molecular Therapuetics, LLC · 2007K073547 · Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel · Anacapa Technologies, Inc. · 2008198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 9 other ancestors4 generations back: 5 other ancestors K073547 · Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel · Anacapa Technologies, Inc. · 2008K063069 · Silvaklenz Skin and Wound Clenser Solution · Medical Molecular Therapuetics, LLC · 2007K023612 · Silverlon Contact Wound Dressing · Argentum International, LLC · 2003K981299 · Silverlon Contact Wound Dressing · Argentum International, LLC · 1998K955453 · Acticoat Silver Coated Dressing · Westaim Technologies, Inc. · 1996K914579 · Silver Foam Wound Dressing · Vitaphore Corp. · 1992−50
  1. Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
  2. 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
  3. 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
  4. 3 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
  5. 2 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
  6. 1 generation backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
  7. This deviceK082858 Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K914579Silver Foam Wound DressingVitaphore Corp.1992—
−5K955453Acticoat Silver Coated DressingWestaim Technologies, Inc.1996—
−4K981299Silverlon Contact Wound DressingArgentum International, LLC1998—
−3K023612Silverlon Contact Wound DressingArgentum International, LLC2003—
−2K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC2007—
−1K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and…Anacapa Technologies, Inc.2008—
0 (this device)K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198920
199310
199520
199730
199820
199920
200130
200220
200410
200510
200610
200710
FIG. 1 — Lineage of K082858, 1992–2009Source: 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 FQH? 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 FQH device

  1. #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 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? (4)

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
*K061467Exsept WC Wound Cleanser
Summary page 1
…Common Name: Wound Cleanser Classification Name: Dressing, Wound, Drug Predicate Devices: ExSept WC Wound CleanerK061467 Silva.Klenz Skin and Wound Cleanser, K063069 Dermacyn Wound Cleanser, K042729…
Alcavis International, Inc.2007—
*K063069Silvaklenz Skin and Wound Clenser Solution
Summary page 1
…Classification Name: Dressing, Wound, Drug Predicate Devices: ExSept WC Wound CleanerK061467 Silva.Klenz Skin and Wound Cleanser, K063069 Dermacyn Wound Cleanser, K042729 Anasept Animicrobial Skin and Wound Cleanser, K073…
Medical Molecular Therapuetics, LLC2007—
*K042729Dermacyn Wound Irrigation
Summary page 1
…Predicate Devices: ExSept WC Wound CleanerK061467 Silva.Klenz Skin and Wound Cleanser, K063069 Dermacyn Wound Cleanser, K042729 Anasept Animicrobial Skin and Wound Cleanser, K073547 Device Description: ExSept WC Skin and Wound Cl ean…
Oculus Innovative Sciences, Inc.2005—
*K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel
Summary page 1
…Silva.Klenz Skin and Wound Cleanser, K063069 Dermacyn Wound Cleanser, K042729 Anasept Animicrobial Skin and Wound Cleanser, K073547 Device Description: ExSept WC Skin and Wound Cl eanser is a clear to slight yellow, slight chlorine odor, solution which is i…
Anacapa Technologies, Inc.2008—

Also cleared against K061467: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
  • None of the 27 ancestors has a recall.
  • 1 other device also cites its predicate K061467.

How does its category compare?

All FQH devices

FQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FQH

3in 2023

2007: 12009: 32011: 22012: 12015: 12016: 12020: 32021: 12022: 42023: 32026 (partial year): 2
2007high 4 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FQH

410in 2023

2009: 240 days median2020: 130 days median2022: 136 days median2023: 410 days median
2007high 410 (2023) · low 130 (2020)2026

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

Recalls per year · FQH

2in 2019

2007: 132009: 12010: 72017: 12019: 2
2007high 13 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FQH

835in 2025

2007: 102008: 272009: 702010: 1352011: 832012: 1332013: 1342014: 1942015: 1162016: 1502017: 2432018: 3172019: 3282020: 3932021: 3982022: 1712023: 3332024: 4252025: 835
2007high 835 (2025) · low 10 (2007)2025

MAUDE reports naming product code FQH, 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
20071—1310
20080—027
20093240170
20100—7135
20112—083
20121—0133
20130—0134
20140—0194
20151—0116
20161—0150
20170—1243
20180—0317
20190—2328
202031300393
20211—0398
202241360171
202334100333
20240—0425
20250—0835
20262—0—

What is it indicated for?

OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.

Professional Use: Under supervision of healtheare professionals, ExSept WC Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree bums, grafted and donor sites, and catheter exit sites.

Indications for use as stated in the FDA summary.

Also cleared against K061467

1 other device cites the same predicate.

  • K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC · 2011

More from Alcavis International, Inc.

3 FDA decisions under this applicant name. See the company

  • K061467Exsept WC Wound CleanserAlcavis International, Inc. · 2007
  • K043126Assist Header CleanerAlcavis International, Inc. · 2005

Recent decisions in FQH

The FQH category page

  • K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
  • K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
  • K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
  • K220759Armis VeriCyn Wound WashArmis Biopharma, Inc. · 2023
  • K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited · 2023

https://510kreport.com/device/K082858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082858: Exsept WC Antimicrobial Skin and 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/K082858

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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