510(k) · Cleared
ClearedCleanSmart Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simple Science, LLC · FRO Dressing, Wound, Drug
Cleared on Sep 2, 2015 as substantially equivalent to K113693 (Seriously Clean, Ltd., 2012) and 3 other predicates after a 352-day review. Its family tree reaches back 10 generations to 1992. 4 later devices descend from it.
- Decided
- Sep 2, 2015
- Review
- 352 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K914579 (1992). 44 ancestors in all, the oldest K830708 (1983). 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations between
- 3 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 2 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 1 generation backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- This deviceK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
- Descendant · cites it directly · 3 of its ownK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
- Descendant · 3 generations on · 1 of its ownK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK261023 Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 9 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 8 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 7 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 6 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 5 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 4 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 3 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 2 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 1 generation backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- This deviceK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
Most influential descendants
Showing 4 of 4 · See all- K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC · 2016 · cites it directly3descendants
- K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018 · 2 generations on2descendants
- K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024 · 3 generations on1descendant
- K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −9 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −8 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −7 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −6 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −5 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −4 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −3 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −2 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −1 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| 0 (this device) | K142592 | CleanSmart Wound Cleanser | Simple Science, LLC | 2015 | — |
| +1 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
| +2 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | 2018 | — |
| +3 | K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024 | — |
| +4 | K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113693 | Nixall TM Wound and Skin CareSummary page 4…dicate devices: 1) Nixall™ Wound and Skin Care (OTC and Professional use) manufactured by Seriously Clean LTD, cleared for distribution under 510(k) K113693 (11/12/2012) 2) Puracyn Plus™ Skin and Wound Care (OTC and Professional use) manufactured by Innovacyn, Inc, cle… | 2012 |
| * | K133542 | Puracyn Plus Skin and WoundSummary page 4…13693 (11/12/2012) 2) Puracyn Plus™ Skin and Wound Care (OTC and Professional use) manufactured by Innovacyn, Inc, cleared for distribution under 510(k) K133542 (28/4/2014) 3) Oculus Puracyn™ Skin and Wound Cleanser with Preservatives manufactured by Oculus Innovative Scie… | 2014 |
| * | K090206 | Oculus Puracyn Antimicrobial Skin and Wound CleanserSummary page 4…14) 3) Oculus Puracyn™ Skin and Wound Cleanser with Preservatives manufactured by Oculus Innovative Sciences Inc., cleared for distribution under 510(k) K090206 (02/06/2009) 4) Vashe® Wound Therapy Solution (OTC use) manufactured by PuriCore, Inc. cleared for dis… | 2009 |
| * | K093697 | Vashe Wound Therapy SolutionSummary page 4…er 510(k) K090206 (02/06/2009) 4) Vashe® Wound Therapy Solution (OTC use) manufactured by PuriCore, Inc. cleared for distribution under 510(k) K093697 (13/04/2010) K142592, Page 2 of 3 10.… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial… | 2016 | 3 |
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 23 years and passes through 9 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 44 ancestors have a recall of any class.
- Of its descendants, K160095 (Simple Science, LLC, 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K113693.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
For management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, minor burns and intact skin.
For management 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, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142592: CleanSmart 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/K142592
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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