510(k) · Cleared
ClearedProntosan Wound Gel X
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 Oct 8, 2013 as substantially equivalent to K062212 (Anacapa Technologies, Inc., 2006) and 1 other predicate after a 194-day review. Its family tree reaches back 5 generations to 1992. 3 later devices descend from it.
- Decided
- Oct 8, 2013
- Review
- 194 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914604 (1992). 14 ancestors in all, the oldest K895993 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 4 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 3 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 2 generations backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- 1 generation backK121522 Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012
- This deviceK130857 Prontosan Wound Gel XB.Braun Medical, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK192527 Rochal Antimicrobial Wound GelRochal Industries, LLC · 2020
- Descendant · cites it directly · 1 of its ownK223259 coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK241809 coactiv+™ Antimicrobial Wound GelKane Biotech, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −4 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −3 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −2 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| −1 | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | Polyremedy, Inc. | 2012 | — |
| 0 (this device) | K130857 | Prontosan Wound Gel X | B.Braun Medical, Inc. | 2013 | — |
| +1 | K192527 | Rochal Antimicrobial Wound Gel | Rochal Industries, LLC | 2020 | — |
| +1 | K223259 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | 2023 | — |
| +2 | K241809 | coactiv+™ Antimicrobial Wound Gel | Kane Biotech, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SSummary page 5…osan® Wound Gel X COMMON NAME: Wound dressing Device Classification: Unclassified, Product Code FRO PREDICATE DEVICE: Silver Shield” Antimicrobial Skin and Wound Gel (K062212) PolyFIT™+ Absorbing Antimicrobial Dressings, PolyFIT "+ High Absorbing Antimicrobial Dressings (K121522) DESCRIPTION OF THE DE… | 2006 |
| * | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc)Summary page 5…DICATE DEVICE: Silver Shield” Antimicrobial Skin and Wound Gel (K062212) PolyFIT™+ Absorbing Antimicrobial Dressings, PolyFIT "+ High Absorbing Antimicrobial Dressings (K121522) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION Prontosan Wound Gel X is a ready to use, clear, odorless, amorphou… | 2012 |
What descends from it? (3)
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 21 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K192527 (Rochal Industries, LLC, 2020) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K062212.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1¥ and 2™ degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor bumns (1" degree burns), and abrasions.
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/K130857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130857: Prontosan Wound Gel X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130857
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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