510(k) · Cleared
ClearedProntosan Antimicrobial Wound Gel
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 Mar 17, 2009 as substantially equivalent to K072876 (B.Braun Medical, Inc., 2008) after a 55-day review. Its family tree reaches back 5 generations to 1995. 22 later devices descend from it.
- Decided
- Mar 17, 2009
- Review
- 55 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945802 (1995). 6 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 4 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 3 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 2 generations backK060113 Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
- 1 generation backK072876 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2008
- This deviceK090141 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2009
- Descendant · cites it directly · 21 of its ownK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- Descendant · 2 generations on · 10 of its ownK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- Descendant · 3 generations on · 9 of its ownK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK110744 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2011
- Descendant · 4 generations on · 3 of its ownK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010 · cites it directly21descendants
- K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015 · 2 generations on10descendants
- K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc. · 2015 · 3 generations on9descendants
- K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2011 · 2 generations on4descendants
- K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC · 2016 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −4 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −3 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −2 | K060113 | Dermacyn Wound Care | Oculus Innovative Sciences, Inc. | 2006 | — |
| −1 | K072876 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2008 | — |
| 0 (this device) | K090141 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2009 | — |
| +1 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| +2 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| +3 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| +2 | K110744 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2011 | — |
| +4 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K072876 | Prontosan Wound Irrigation SolutionSummary page 1…n'm Wound Irrigation Solution B. Braun Medical, Inc. Regulatory Class: Unclassified, Product Code: FRO 510(k) K072876, June 19, 2008 DESCRIPTION: Prontosan"Tm Wound Gel is a clear, colourless liquid-gel… | 2008 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101882 | Prontosan Antimicrobial Wound Gel | 2010 | 21 |
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 14 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K101882 (B.Braun Medical, Inc., 2010) has gone furthest, with 21 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. 2009, 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 Tm Wound Gel is intended for moistening and cleansing wounds by maceration of wound coatings and for moistening and lubricating absorbent wound dressings for ulcers, bums, post-surgical wounds, and abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090141: Prontosan Antimicrobial Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090141
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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