510(k) · Cleared
ClearedIrrisept Antimicrobial Wound Lavage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irrimax Corporation · FRO Dressing, Wound, Drug
Cleared on Jun 18, 2024 as substantially equivalent to K210536 (Irrimax Corporation, 2021) after a 111-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jun 18, 2024
- Review
- 111 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K914579 (1992). 36 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 7 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 6 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 5 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 4 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 3 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 2 generations backK160192 Atteris Antimicrobial Skin & Wound CleanserRochal Industries, LLC · 2016
- 1 generation backK210536 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021
- This deviceK240552 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −7 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −6 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −5 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −4 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −3 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −2 | K160192 | Atteris Antimicrobial Skin & Wound Cleanser | Rochal Industries, LLC | 2016 | — |
| −1 | K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021 | — |
| 0 (this device) | K240552 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K210536 | Irrisept Antimicrobial Wound LavageSummary page 5…e); Class II (21 CFR 880.5475) Product Code: FRO (Dressing, Wound, Drug); Unclassified (pre- amendment) cleared under K210536 Device Description: Irrisept® Antimicrobial Wound Lavage is a single-use, self- contained irrigat… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 36 ancestors has a recall of any class.
- 2 other devices also cite its predicate K210536.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms, from wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240552: Irrisept Antimicrobial Wound Lavage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240552
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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