510(k) · Cleared
ClearedNawalution Skin and Wound Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nawa Heilmittel GmbH · FRO Dressing, Wound, Drug
Cleared on Oct 31, 2014 as substantially equivalent to K113820 (Novabay Pharmaceuticals, 2012) and 4 other predicates after a 133-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 133 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K914579 (1992). 51 ancestors in all, the oldest K830708 (1983). 2 later devices descend from it, 2 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 backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 1 generation backK131542 Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc. · 2013
- This deviceK141660 Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014
- Descendant · cites it directly · 0 of its ownK252759 revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK231564 Skin and Wound CleanserWinner Medical Co., Ltd. · 2023
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 backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 1 generation backK131542 Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc. · 2013
- This deviceK141660 Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014
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 |
|---|---|---|---|---|---|
| −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 | K113820 | Neutrophase Antimicrobial Wound Cleanser | Novabay Pharmaceuticals | 2012 | — |
| −1 | K131542 | Neutrophase (R) Skin and Wound Cleanser Otc | Novabay Pharmaceuticals, Inc. | 2013 | — |
| 0 (this device) | K141660 | Nawalution Skin and Wound Cleanser | Nawa Heilmittel GmbH | 2014 | — |
| +1 | K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026 | — |
| +1 | K231564 | Skin and Wound Cleanser | Winner Medical Co., Ltd. | 2023 | — |
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 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K113820 | Neutrophase Antimicrobial Wound CleanserSummary page 4…Classification: Unclassified Predicate Devices: NeutroPhase Skin and Wound Cleanser, NovaBay Pharmaceuticals, Inc., K113820, Product Code FRO, Unclassified NeutroPhase Skin and Wound Cleanser OT… | 2012 |
| * | K131542 | Neutrophase (R) Skin and Wound Cleanser OtcSummary page 4…Unclassified NeutroPhase Skin and Wound Cleanser OTC, NovaBay Pharmaceuticals, Inc., K131542, Product Code FRO, Unclassified Prontosan Wound Irrigation Solution, B… | 2013 |
| * | K072876 | Prontosan Wound Irrigation SolutionSummary page 4…de FRO, Unclassified Prontosan Wound Irrigation Solution, B. Braun Medical, Inc., K072876, Product Code FRO, Unclassified Prontosan Wound Irrigation Solution, B. Braun Medical,… | 2008 |
| * | K110744 | Prontosan Wound Irrigation SolutionSummary page 4…Inc., K072876, Product Code FRO, Unclassified Prontosan Wound Irrigation Solution, B. Braun Medical, Inc., K110744, Product Code FRO, Unclassified BioDerm Wound Spray, BioDerm Sciences, Inc., K042084,… | 2011 |
| * | K042084 | Bioderm Sciences Wound Healing SpraySummary page 4…, B. Braun Medical, Inc., K110744, Product Code FRO, Unclassified BioDerm Wound Spray, BioDerm Sciences, Inc., K042084, Product Code FRO, Unclassified. Device Description: The subject device of this submission… | 2005 |
What descends from it? (2)
2 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 22 years and passes through 10 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 51 ancestors has a recall of any class.
- Of its descendants, K252759 (Kane Biotech, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K113820.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
NAWAlution for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for…
Read the full statement (107 words)
NAWAlution for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
NAWAlution for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141660: Nawalution Skin and 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/K141660
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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