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 Nov 3, 2010 as substantially equivalent to K090141 (B.Braun Medical, Inc., 2009) and 1 other predicate after a 120-day review. Its family tree reaches back 6 generations to 1992. 21 later devices descend from it.
- Decided
- Nov 3, 2010
- Review
- 120 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914579 (1992). 29 ancestors in all, the oldest K890354 (1989). 21 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 2 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 1 generation backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- This deviceK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- Descendant · cites it directly · 10 of its ownK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- Descendant · 2 generations on · 9 of its ownK150799 Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel…Innovacyn, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK110744 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK160095 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple…Simple Science, LLC · 2016
- Descendant · 4 generations on · 2 of its ownK181074 Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015 · cites it directly10descendants
- K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc. · 2015 · 2 generations on9descendants
- K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2011 · cites it directly4descendants
- K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC · 2016 · 3 generations on3descendants
- K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −2 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −1 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| 0 (this device) | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| +1 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| +2 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| +1 | K110744 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2011 | — |
| +3 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science… | Simple Science, LLC | 2016 | — |
| +4 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser | Simple Science, LLC | 2018 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K090141 | Prontosan Antimicrobial Wound GelSummary page 1…eanser, Wound Dressing DEVICE CLASSifICATION: Class 1I, Product Code FRO, Unclassified PREDICATE DEVICES: Prontosan® Wound Gel, B. Braun Medical, Inc., K090141 Class II, FRO, Unclassified Anasept® Antimicrobial Skin and Wound Gel, Anacapa… | 2009 |
| * | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelSummary page 1…Inc., K090141 Class II, FRO, Unclassified Anasept® Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc., K073 547, Class 11, FRO, Unclassified DESCRIPTION: Prontosan® Wound Gel is a clear, colorless and virtually… | 2008 |
What descends from it? (21)
See all 215 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 18 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K141863 (Puricore, Inc., 2015) has gone furthest, with 10 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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: Prontosan Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasion, laceration, and minor burns.
Professional Use: Prontosan Wound Gel is intend to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101882: 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/K101882
Report an extraction error
Are you the manufacturer?
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