510(k) · Cleared
ClearedGranudacyn® Wound Irrigation Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
P.G.F. Industry Solutions GmbH · FRO Dressing, Wound, Drug
Cleared on Jul 22, 2025 as substantially equivalent to K131848 (Puricore, Inc., 2014) after a 263-day review. Its family tree reaches back 10 generations to 1992. 1 later device descends from it.
- Decided
- Jul 22, 2025
- Review
- 263 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K914579 (1992). 55 ancestors in all, the oldest K830708 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations between
- 3 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 2 generations backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 1 generation backK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- This deviceK243415 Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025
- Descendant · cites it directly · 0 of its ownK261023 Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 9 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 8 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 7 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 6 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 5 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 4 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 3 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 2 generations backK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
- 1 generation backK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
- This deviceK243415 Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH · 2025
Most influential descendants
Showing 1 of 1 · See all- K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −9 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −8 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −7 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −6 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −5 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −4 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −3 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −2 | K113820 | Neutrophase Antimicrobial Wound Cleanser | Novabay Pharmaceuticals | 2012 | — |
| −1 | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) | Puricore, Inc. | 2014 | — |
| 0 (this device) | K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025 | — |
| +1 | K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K131848 | Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Summary page 5…nclassified Unclassified Reason: Pre-Amendment Product Code: FRO Predicate Device Name: Vashe® Wound Solution (K131848) Reference Device Name: Microdacyn® Wound Care Solution (K233399) Device Description: Granudacyn® Wound Wash… | 2014 |
| † | K233399 | Microdacyn Wound Care Solution | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261023 | Microdacyn Wound Irrigation Solution | 2026 | 0 |
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 33 years and passes through 9 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 55 ancestors have a recall of any class.
- Of its descendants, K261023 (Sonoma Pharmaceuticals, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K131848.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.
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/K243415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243415: Granudacyn® 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/K243415
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