510(k) · Cleared
ClearedAnasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anacapa Technologies, Inc. · FRO Dressing, Wound, Drug
Cleared on Apr 23, 2008 as substantially equivalent to K062212 (Anacapa Technologies, Inc., 2006) and 2 other predicates after a 127-day review. Its family tree reaches back 5 generations to 1992. 66 later devices descend from it.
- Decided
- Apr 23, 2008
- Review
- 127 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K914579 (1992). 25 ancestors in all, the oldest K890354 (1989). 66 later devices descend from it, 17 citing it directly.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 1 generation backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- This deviceK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · cites it directly · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- Descendant · cites it directly · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 2 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- Descendant · cites it directly · 21 of its ownK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- Descendant · cites it directly · 20 of its ownK093697 Vashe Wound Therapy SolutionPuricore, Inc. · 2010
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · cites it directly37descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · cites it directly31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 2 generations on25descendants
- K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010 · cites it directly21descendants
- K093697Vashe Wound Therapy SolutionPuricore, Inc. · 2010 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −1 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| 0 (this device) | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +1 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| +1 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +2 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| +1 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| +1 | K093697 | Vashe Wound Therapy Solution | Puricore, Inc. | 2010 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 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.
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 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 |
|---|---|---|---|
| * | K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SSummary page 1…ntial equivalence comparison: AnaseptTM Antimicrobial Skin and Wound Gel is substantially equivalent to Silver ShieldTM Antimicrobial Skin and Wound Gel 510(K) # K062212 manufactured and distributed by Anacapa TM Technologies, Inc Description of Device: Anasept TM Antimicrobial Skin and… | 2006 |
| * | K042729 | Dermacyn Wound IrrigationSummary page 3…s 510(K) submission, AnaseptTM Antimicrobial Skin and Wound Cleanser is similar in function and intended use as the predicate devices DermacynTM Wound Cleanser, 510(K) # K042729, and Silvaklenz TM Antibacterial Silver Skin and Wound Cleanser, K063069. The safety evaluation meets the requirements as set for… | 2005 |
| * | K063069 | Silvaklenz Skin and Wound Clenser SolutionSummary page 3…imilar in function and intended use as the predicate devices DermacynTM Wound Cleanser, 510(K) # K042729, and Silvaklenz TM Antibacterial Silver Skin and Wound Cleanser, K063069. The safety evaluation meets the requirements as set forth by USP and ISO. The indications of use, device description and perform… | 2007 |
What descends from it? (66)
See all 6617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | 2009 | 37 |
| K100918 | Vashe Wound Therapy System Model: 9000-0014 | 2010 | 31 |
| K101882 | Prontosan Antimicrobial Wound Gel | 2010 | 21 |
| K093697 | Vashe Wound Therapy Solution | 2010 | 20 |
| K113693 | Nixall TM Wound and Skin Care | 2012 | 15 |
| K113820 | Neutrophase Antimicrobial Wound Cleanser | 2012 | 15 |
| K141863 | Puricore Wound Hydrogel Spray Dressing | 2015 | 10 |
| K090791 | Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5% | 2009 | 10 |
| K160192 | Atteris Antimicrobial Skin & Wound Cleanser | 2016 | 9 |
| K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus… | 2015 | 9 |
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 16 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K090206 (Oculus Innovative Sciences, Inc., 2009) has gone furthest, with 37 descendants of its own.
- 7 other devices also cite its predicate K062212.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
OTC: AnaseptTM Antimicrobial Skin and Wound Cleanser is intended for OTC use for mechanical cleansing of dirt and debris form skin abrasions, minor irritations, cuts, exit sites and intact skin. Professional Use: AnaseptTM Antimicrobial Skin and Wound Cleanser is intended for professional use for cleansing and removal of foreign material including micro-organisms and debris from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post…
Read the full statement (154 words)
OTC: AnaseptTM Antimicrobial Skin and Wound Cleanser is intended for OTC use for mechanical cleansing of dirt and debris form skin abrasions, minor irritations, cuts, exit sites and intact skin.
Professional Use: AnaseptTM Antimicrobial Skin and Wound Cleanser is intended for professional use for cleansing and removal of foreign material including micro-organisms and debris from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree bums, grafted and donor sites.
OTC: AnaseptTM Antimicrobial Skin and Wound Gel is intended for OTC use for management of Skin Abrasions and lacerations, minor irritations, cuts, exit sites and intact skin.
Professional Use: Anaseptrm Antimicrobial Skin and Wound Gel is intended to be used by health care professionals for the maniagement of wounds such as Stage I-IV Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Post Surgical Wounds, First and Second Degree Burns, Grafted and Donor Sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073547
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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