510(k) · Cleared
ClearedExsept Skin and Wound Cleanser with Antimicrobial Preservative
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcavis Hdc, LLC · FQH Lavage, Jet
Cleared on Dec 14, 2011 as substantially equivalent to K061467 (Alcavis International, Inc., 2007) and 4 other predicates after a 218-day review. Its family tree reaches back 7 generations to 1992. 9 later devices descend from it.
- Decided
- Dec 14, 2011
- Review
- 218 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K914579 (1992). 28 ancestors in all, the oldest K890354 (1989). 9 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 5 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 4 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 3 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 2 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 1 generation backK090791 Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%Century Pharmaceuticals, Inc. · 2009
- This deviceK111313 Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC · 2011
- Descendant · cites it directly · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
- Descendant · 2 generations on · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016
- Descendant · 2 generations on · 1 of its ownK243415 Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025
- Descendant · 3 generations on · 1 of its ownK213514 Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014 · cites it directly8descendants
- K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 2 generations on4descendants
- K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 2 generations on3descendants
- K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025 · 2 generations on1descendant
- K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −6 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −5 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −4 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −3 | 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 | K090791 | Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5% | Century Pharmaceuticals, Inc. | 2009 | — |
| 0 (this device) | K111313 | Exsept Skin and Wound Cleanser with Antimicrobial Preservative | Alcavis Hdc, LLC | 2011 | — |
| +1 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| +2 | K141012 | Hydrocleanse Wound Care Solution | Oculus Innovative Sciences | 2014 | — |
| +2 | K161034 | Microcyn Plus Wound Care Solution | Oculus Innovative Sciences | 2016 | — |
| +2 | K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025 | — |
| +3 | K213514 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 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 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 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? (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 |
|---|---|---|---|
| * | K061467 | Exsept WC Wound CleanserSummary page 1…Common Name: Wound Cleanser Classification Name: Dressing, Wound, Drug Predicate Devices: ExSept WC Wound Cleaner, K061467 SilvaKlenz Skin and Wound Cleanser, K(063069 Dermacyn Wound Cleanser, K042729… | 2007 |
| * | K063069 | Silvaklenz Skin and Wound Clenser SolutionSummary page 1…Classification Name: Dressing, Wound, Drug Predicate Devices: ExSept WC Wound Cleaner, K061467 SilvaKlenz Skin and Wound Cleanser, K(063069 Dermacyn Wound Cleanser, K042729 Anasept Animicrobial Skin and Wound Cleanser,… | 2007 |
| * | K042729 | Dermacyn Wound IrrigationSummary page 1…cate Devices: ExSept WC Wound Cleaner, K061467 SilvaKlenz Skin and Wound Cleanser, K(063069 Dermacyn Wound Cleanser, K042729 Anasept Animicrobial Skin and Wound Cleanser, K(073547 Dakin's Wound Cleanser,… | 2005 |
| * | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelSummary page 1…lenz Skin and Wound Cleanser, K(063069 Dermacyn Wound Cleanser, K042729 Anasept Animicrobial Skin and Wound Cleanser, K(073547 Dakin's Wound Cleanser, K(090791 Device Description: ExSept Skin and Wound Cleanser is a clear to sli… | 2008 |
| * | K090791 | Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%Summary page 1…Dermacyn Wound Cleanser, K042729 Anasept Animicrobial Skin and Wound Cleanser, K(073547 Dakin's Wound Cleanser, K(090791 Device Description: ExSept Skin and Wound Cleanser is a clear to slight yellow, slight chlorine odor, solution which isinte… | 2009 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | 2014 | 8 |
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 19 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K131848 (Puricore, Inc., 2014) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K061467.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FQH
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FQH
410in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FQH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQH
835in 2025
MAUDE reports naming product code FQH, 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 | 1 | — | 13 | 10 |
| 2008 | 0 | — | 0 | 27 |
| 2009 | 3 | 240 | 1 | 70 |
| 2010 | 0 | — | 7 | 135 |
| 2011 | 2 | — | 0 | 83 |
| 2012 | 1 | — | 0 | 133 |
| 2013 | 0 | — | 0 | 134 |
| 2014 | 0 | — | 0 | 194 |
| 2015 | 1 | — | 0 | 116 |
| 2016 | 1 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 243 |
| 2018 | 0 | — | 0 | 317 |
| 2019 | 0 | — | 2 | 328 |
| 2020 | 3 | 130 | 0 | 393 |
| 2021 | 1 | — | 0 | 398 |
| 2022 | 4 | 136 | 0 | 171 |
| 2023 | 3 | 410 | 0 | 333 |
| 2024 | 0 | — | 0 | 425 |
| 2025 | 0 | — | 0 | 835 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
OTC: ExSept Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor skin and nail irritations, minor cuts, and intact skin.
Professional Use: Under supervision of healthcare professionals, ExSept 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, ingrown toe nails, post surgical wounds, first and second degree burns, grafted and donor sites, and exit sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111313: Exsept Skin and Wound Cleanser with Antimicrobial Preservative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111313
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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