510(k) · Cleared
ClearedProntosan Wound Irrigation Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FRO Dressing, Wound, Drug
Cleared on Apr 6, 2011 as substantially equivalent to K072876 (B.Braun Medical, Inc., 2008) and 1 other predicate after a 20-day review. Its family tree reaches back 7 generations to 1992. 4 later devices descend from it.
- Decided
- Apr 6, 2011
- Review
- 20 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K914579 (1992). 30 ancestors in all, the oldest K890354 (1989). 4 later devices descend from it, 2 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 backK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- This deviceK110744 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK141660 Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK252759 revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250642 LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK231564 Skin and Wound CleanserWinner Medical Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH · 2014 · cites it directly2descendants
- K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc. · 2026 · 2 generations on0descendants
- K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd. · 2025 · cites it directly0descendants
- K231564Skin and Wound CleanserWinner Medical Co., Ltd. · 2023 · 2 generations on0descendants
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 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| 0 (this device) | K110744 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2011 | — |
| +1 | K141660 | Nawalution Skin and Wound Cleanser | Nawa Heilmittel GmbH | 2014 | — |
| +2 | K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026 | — |
| +1 | K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | 2025 | — |
| +2 | K231564 | Skin and Wound Cleanser | Winner Medical Co., Ltd. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K072876 | Prontosan Wound Irrigation SolutionSummary page 1…DEVICE CLASSIFICATION: Product Code FRO, Unclassified PREDICATE DEVICES: Prontosan® Wound Irrigation Solution, B. Braun Me dical, Inc., K072876, Class II, Product Code FRO, Unclassified Prontosan® Wound Gel, B.Braun Medical, Inc., K101882,… | 2008 |
| * | K101882 | Prontosan Antimicrobial Wound GelSummary page 1…B. Braun Me dical, Inc., K072876, Class II, Product Code FRO, Unclassified Prontosan® Wound Gel, B.Braun Medical, Inc., K101882, Class 11, Product Code FRO, Unclassified DESCRIPTION: The subject device of' th… | 2010 |
What descends from it? (4)
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 19 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 30 ancestors has a recall.
- Of its descendants, K141660 (Nawa Heilmittel GmbH, 2014) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K072876.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Prontosan® Wound Irrigation Solution is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor bums.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110744: Prontosan Wound Irrigation Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110744
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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