510(k) · Cleared
ClearedNixall Antimicrobial Solutions™ Skin & Wound Hydrogel
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 May 2, 2025 as substantially equivalent to K150799 (Innovacyn, Inc., 2015) after a 176-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- May 2, 2025
- Review
- 176 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K914579 (1992). 49 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- Root · 9 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations between
- 3 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 2 generations backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- 1 generation backK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- This deviceK243457 Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 8 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 7 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 6 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 5 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 4 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 3 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 2 generations backK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- 1 generation backK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- This deviceK243457 Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −8 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −7 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −6 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −5 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −4 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −3 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| −2 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| −1 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| 0 (this device) | K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel | Seriously Clean, Ltd. | 2025 | — |
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 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Summary page 5…ED: January 12, 2024 PREDICATE DEVICE(S): Substantial equivalence is claimed to the following devices as related to intended use, design, and material characteristics: K150799 • Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel; • Puracyn® Plus Antimicrobial Hydrogel Professional Formul… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 9 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 49 ancestors has a recall of any class.
- 4 other devices also cite its predicate K150799.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is intended to be used for Over-The-Counter and Prescription Use. The Over-The-Counter use is intended for the following indications: • For use on minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. • To moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates…
Read the full statement (162 words)
The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is intended to be used for Over-The-Counter and Prescription Use. The Over-The-Counter use is intended for the following indications:
• For use on minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns.
• To moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement.
The Prescription Use Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is indicated for the following uses:
• Use with dermal irritation, sores, injuries and ulcers of dermal tissues.
• Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions.
• Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243457: Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243457
Report an extraction error
Are you the manufacturer?
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