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 · FQH Lavage, Jet
Cleared on May 28, 2021 as substantially equivalent to K202222 (Irrimax Corporation, 2020) and 1 other predicate after a 93-day review. Its family tree reaches back 7 generations to 1992. 6 later devices descend from it.
- Decided
- May 28, 2021
- Review
- 93 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K914579 (1992). 35 ancestors in all, the oldest K890354 (1989). 6 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 5 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 4 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 3 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 2 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 1 generation backK160192 Atteris Antimicrobial Skin & Wound CleanserRochal Industries, LLC · 2016
- This deviceK210536 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021
- Descendant · cites it directly · 3 of its ownK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
- Descendant · 2 generations on · 2 of its ownK221504 BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022
- Descendant · 3 generations on · 0 of its ownK253996 BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
- Descendant · 3 generations on · 0 of its ownK253445 BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
- Descendant · cites it directly · 0 of its ownK240552 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022 · cites it directly3descendants
- K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022 · 2 generations on2descendants
- K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026 · 3 generations on0descendants
- K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026 · 3 generations on0descendants
- K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −6 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −5 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −4 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −3 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −2 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −1 | K160192 | Atteris Antimicrobial Skin & Wound Cleanser | Rochal Industries, LLC | 2016 | — |
| 0 (this device) | K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021 | — |
| +1 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
| +2 | K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022 | — |
| +3 | K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026 | — |
| +3 | K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 FQH? 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 FQH device
- #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 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 |
|---|---|---|---|
| * | K202222 | Irrisept Wound Debridement and Cleansing SystemSummary page 4…Drug); Unclassified (pre-amendment) Applicant: Irrimax Corporation Cleared under K202222 on December 14, 2020 SECONDARY Atteris Antimicrobial Skin and Wound PRE… | 2020 |
| * | K160192 | Atteris Antimicrobial Skin & Wound CleanserSummary page 4…Drug); Unclassified (pre-amendment) Applicant: Rochal Industries, LLC Cleared under K160192 on July 28, 2016 DEVICE DESCRIPTION: Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation dev… | 2016 |
What descends from it? (6)
3 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 29 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 35 ancestors has a recall of any class.
- Of its descendants, K213616 (Becton, Dickinson and Company, 2022) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FQH
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FQH
410in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FQH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQH
835in 2025
MAUDE reports naming product code FQH, 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 | 1 | — | 13 | 10 |
| 2008 | 0 | — | 0 | 27 |
| 2009 | 3 | 240 | 1 | 70 |
| 2010 | 0 | — | 7 | 135 |
| 2011 | 2 | — | 0 | 83 |
| 2012 | 1 | — | 0 | 133 |
| 2013 | 0 | — | 0 | 134 |
| 2014 | 0 | — | 0 | 194 |
| 2015 | 1 | — | 0 | 116 |
| 2016 | 1 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 243 |
| 2018 | 0 | — | 0 | 317 |
| 2019 | 0 | — | 2 | 328 |
| 2020 | 3 | 130 | 0 | 393 |
| 2021 | 1 | — | 0 | 398 |
| 2022 | 4 | 136 | 0 | 171 |
| 2023 | 3 | 410 | 0 | 333 |
| 2024 | 0 | — | 0 | 425 |
| 2025 | 0 | — | 0 | 835 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
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/K210536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210536: 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/K210536
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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