510(k) · Cleared
ClearedNixall TM Wound and Skin Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seriously Clean, Ltd. · FRO Dressing, Wound, Drug
Cleared on Dec 11, 2012 as substantially equivalent to K090206 (Oculus Innovative Sciences, Inc., 2009) and 2 other predicates after a 361-day review. Its family tree reaches back 7 generations to 1992. 15 later devices descend from it.
- Decided
- Dec 11, 2012
- Review
- 361 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K914579 (1992). 32 ancestors in all, the oldest K890354 (1989). 15 later devices descend from it, 3 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 backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- This deviceK113693 Nixall TM Wound and Skin CareSeriously Clean, Ltd. · 2012
- Descendant · cites it directly · 14 of its ownK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK181428 Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- Descendant · cites it directly · 4 of its ownK142592 CleanSmart Wound CleanserSimple Science, LLC · 2015
- Descendant · 4 generations on · 3 of its ownK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K133542Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014 · cites it directly14descendants
- K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019 · 2 generations on5descendants
- K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020 · 3 generations on4descendants
- K142592CleanSmart Wound CleanserSimple Science, LLC · 2015 · cites it directly4descendants
- K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022 · 4 generations on3descendants
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 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| 0 (this device) | K113693 | Nixall TM Wound and Skin Care | Seriously Clean, Ltd. | 2012 | — |
| +1 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| +2 | K181428 | Clyra Wound Irrigation Solution | Clyra Medical Technologies, Inc. | 2019 | — |
| +3 | K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020 | — |
| +1 | K142592 | CleanSmart Wound Cleanser | Simple Science, LLC | 2015 | — |
| +4 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
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 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K090206 | Oculus Puracyn Antimicrobial Skin and Wound CleanserSummary page 1…e Class: Unclassified Product Code: FRO Legally Marketed Device for substantial equivalence Comparison: Oculus PuracynTM Skin and Wound Cleanserwith Preservatives K090206 Vashe TM Wound CleanserKO92232 Anasept T" Antimicrobial Skin and Wound Gel K073547 Device Description: NiXa I… | 2009 |
| * | K092232 | Modification to:Vashe Wound Cleansing System, Model 9000-0014Summary page 2…ion concludesthat NiXaITM Wound and Skin Care issubstantially equivalentto predicate devices, Puracyn TM Skin and Wound Cleanser, 510(k) #K090206, and Vashe TM , 510(k) #K092232, and Anase pt TM, 510(k) #K<073547. Pasted from<fl:/C\ourns/2ad/25tisi\M/2Ocuet\DA\FA/250/2Oon/2Ooiain \51O%20K%/2Osunirrvdocx>… | 2009 |
| * | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelSummary page 1…omparison: Oculus PuracynTM Skin and Wound Cleanserwith Preservatives K090206 Vashe TM Wound CleanserKO92232 Anasept T" Antimicrobial Skin and Wound Gel K073547 Device Description: NiXa ITM Wound and Skin Care isa clear solution that aids inthe removal of debris and foreign… | 2008 |
What descends from it? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 32 ancestors have a recall of any class.
- Of its descendants, K133542 (Innovacyn, Inc., 2014) has gone furthest, with 14 descendants of its own.
- 7 other devices also cite its predicate K090206.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Nixallm Wound and Skin Care, Is intended for over the counter and professional use as follows:
OTC: Nixall"' Wound and Skin Care is for the management of, the irrigation of, the moistening of, and lubrication of minor skin abrasions, minor lacerations, minor burns, minor irritations, minor cuts, and intact skin.
Prescription Use: Nixallm Wound and Skin Care is intended to be used by health care professionals in the management, via dlebridement of wounds such as stage I-V pressure ulcers, diabetic foot 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/K113693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113693: Nixall TM Wound and Skin Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113693
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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