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 Jun 19, 2008 as substantially equivalent to K060113 (Oculus Innovative Sciences, Inc., 2006) after a 254-day review. Its family tree reaches back 4 generations to 1995. 29 later devices descend from it.
- Decided
- Jun 19, 2008
- Review
- 254 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945802 (1995). 5 ancestors in all. 29 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 3 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 2 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- 1 generation backK060113 Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006
- This deviceK072876 Prontosan Wound Irrigation SolutionB.Braun Medical, Inc. · 2008
- Descendant · cites it directly · 22 of its ownK090141 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2009
- Descendant · 2 generations on · 21 of its ownK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010
- Descendant · 3 generations on · 10 of its ownK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
- Descendant · 4 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 ownK161165 Next Science Irrigation SolutionNext Science, LLC · 2016
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K090141Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2009 · cites it directly22descendants
- K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010 · 2 generations on21descendants
- K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015 · 3 generations on10descendants
- K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc. · 2015 · 4 generations on9descendants
- K161165Next Science Irrigation SolutionNext Science, LLC · 2016 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −3 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −2 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| −1 | K060113 | Dermacyn Wound Care | Oculus Innovative Sciences, Inc. | 2006 | — |
| 0 (this device) | K072876 | Prontosan Wound Irrigation Solution | B.Braun Medical, Inc. | 2008 | — |
| +1 | K090141 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2009 | — |
| +2 | K101882 | Prontosan Antimicrobial Wound Gel | B.Braun Medical, Inc. | 2010 | — |
| +3 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
| +4 | K150799 | Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn… | Innovacyn, Inc. | 2015 | — |
| +1 | K161165 | Next Science Irrigation Solution | Next 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K060113 | Dermacyn Wound CareSummary page 1…nd Care solution Oculus Innovative Sciences, Inc. Regulatory Class: Unclassified, Product Code: FRO 510(k) K060113 March 19, 2007 DESCRIPTION: Prontosan Wound Irrigation Solution is a clear, colorless liquid co… | 2006 |
What descends from it? (29)
See all 295 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090141 | Prontosan Antimicrobial Wound Gel | 2009 | 22 |
| K161165 | Next Science Irrigation Solution | 2016 | 4 |
| K110744 | Prontosan Wound Irrigation Solution | 2011 | 4 |
| K141660 | Nawalution Skin and Wound Cleanser | 2014 | 2 |
| K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL… | 2016 | 1 |
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 13 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090141 (B.Braun Medical, Inc., 2009) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K060113.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072876: 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/K072876
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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