510(k) · Cleared
ClearedIrrisept Wound Debridement and Cleansing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irrimax Corporation · FQH Lavage, Jet
Cleared on Dec 14, 2020 as substantially equivalent to K080779 (Irrimax Corporation, 2009) after a 130-day review. Its family tree reaches back 4 generations to 1995. 7 later devices descend from it.
- Decided
- Dec 14, 2020
- Review
- 130 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945802 (1995). 11 ancestors in all, the oldest K895920 (1991). 7 later devices descend from it, 1 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 backK080779 Irrisept Wound Cleansing SystemIrrimax Corporation · 2009 · Recalled
- This deviceK202222 Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020
- Descendant · cites it directly · 6 of its ownK210536 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021
- Descendant · 2 generations on · 3 of its ownK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
- Descendant · 3 generations on · 2 of its ownK221504 BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022
- Descendant · 4 generations on · 0 of its ownK253996 BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
- Descendant · 4 generations on · 0 of its ownK253445 BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021 · cites it directly6descendants
- K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022 · 2 generations on3descendants
- K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022 · 3 generations on2descendants
- K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026 · 4 generations on0descendants
- K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026 · 4 generations on0descendants
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 | K080779 | Irrisept Wound Cleansing System | Irrimax Corporation | 2009 | 2 |
| 0 (this device) | K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020 | — |
| +1 | K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021 | — |
| +2 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
| +3 | K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022 | — |
| +4 | K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026 | — |
| +4 | K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K080779 | Irrisept Wound Cleansing SystemSummary page 4…-amendment) PRODUCT CODE: FQH; FRO PREDICATE DEVICE: Irrisept® Wound Debridement and Cleansing System (K080779) • Product Code FQH (Jet Lavage); Class II (21 CFR 880.547… | 2009 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210536 | Irrisept Antimicrobial Wound Lavage | 2021 | 6 |
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 25 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K210536 (Irrimax Corporation, 2021) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K080779.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
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/K202222 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202222: Irrisept Wound Debridement and Cleansing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202222
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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