510(k) · Cleared
ClearedActolind® (06.3637. Actolind® Gel Plus)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACTO GmbH · FRO Dressing, Wound, Drug
Cleared on Sep 22, 2026 as substantially equivalent to K163430 (B.Braun Medical, Inc., 2017) after a 273-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Sep 22, 2026
- Review
- 273 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K914579 (1992). 31 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 7 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 6 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 5 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 4 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 3 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 2 generations backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- 1 generation backK163430 Prontosan Wound GelB.Braun Medical, Inc. · 2017
- This deviceK254168 Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −7 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −6 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −5 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −4 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −3 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −2 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| −1 | K163430 | Prontosan Wound Gel | B.Braun Medical, Inc. | 2017 | — |
| 0 (this device) | K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | 2026 | — |
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 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K163430 | Prontosan Wound GelSummary page 5…Predicate Device Prontosan Wound Gel B. Braun Medical, Inc. Regulatory Class: Unclassified, Product Code: FRO 510(k) K163430, May 23, 2017 6. Common Name Wound Cleanser, Wound Dressing, Wound Care Gel 7. Device Classifica… | 2017 |
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 34 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- None of the 31 ancestors has a recall.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
OTC Use: Actolind® Gel Plus is intended to cleanse and moisten the wound bed and for the management of minor cuts, minor abrasions, minor lacerations, and minor burns.
Professional Use: Actolind® Gel Plus is intended to cleanse and moisten the wound bed and for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and superficial partial thickness (2nd degree) burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254168: Actolind® (06.3637. Actolind® Gel Plus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254168
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026