510(k) · Cleared
ClearedSimple Science Antimicrobial Facial and Eyelid 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 Aug 17, 2018 as substantially equivalent to K160095 (Simple Science, LLC, 2016) after a 115-day review. Its family tree reaches back 12 generations to 1992. 2 later devices descend from it.
- Decided
- Aug 17, 2018
- Review
- 115 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K914579 (1992). 62 ancestors in all, the oldest K830708 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 8 generations between
- 3 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 2 generations backK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
- 1 generation backK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- This deviceK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
- Descendant · cites it directly · 1 of its ownK233399 Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261023 Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 11 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 10 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 9 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 8 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 7 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 6 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 5 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 4 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 3 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 2 generations backK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
- 1 generation backK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- This deviceK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −11 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −10 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −9 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −8 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −7 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −6 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −5 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −4 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −3 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| −2 | K142592 | CleanSmart Wound Cleanser | Simple Science, LLC | 2015 | — |
| −1 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
| 0 (this device) | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | 2018 | — |
| +1 | K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024 | — |
| +2 | 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 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Summary page 4…1) Simple Science Antimicrobial Wound and Skin Cleanser (OTC and Professional use) manufactured by Simple Science LLC, cleared for distribution under 510(k) K160095 (June-10th-2016) 10. Description of Device Simple Science Antimicrobial Facial & Eyelid Cleanser is… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233399 | Microdacyn Wound Care Solution | 2024 | 1 |
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 26 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 62 ancestors have a recall of any class.
- Of its descendants, K233399 (Sonoma Pharmaceuticals, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Over-the-Counter Use: For management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181074: Simple Science Antimicrobial Facial and Eyelid Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181074
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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