510(k) · Cleared
Recalled · Class II · 2019Irrisept Wound 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 Feb 4, 2009 as substantially equivalent to K022670 (Carrington Laboratories, Inc., 2002) and 4 other predicates after a 322-day review. Its family tree reaches back 3 generations to 1995. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 4, 2009
- Review
- 322 days
- Class
- Class II
- Product code
- FQH
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 3 generations to K945802 (1995). 10 ancestors in all, the oldest K895920 (1991). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
- 2 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
- 1 generation backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
- This deviceK080779 Irrisept Wound Cleansing SystemIrrimax Corporation · 2009
- Descendant · cites it directly · 7 of its ownK202222 Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020
- Descendant · 2 generations on · 6 of its ownK210536 Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021
- Descendant · cites it directly · 4 of its ownK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation · 2020 · cites it directly7descendants
- K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation · 2021 · 2 generations on6descendants
- K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020 · cites it directly4descendants
- K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022 · 2 generations on3descendants
- K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945802 | Dermagran Wound Cleanser with Zinc | Derma Sciences, Inc. | 1995 | — |
| −2 | K965120 | Allclenz Wound Cleanser | Dpt Laboratories, Ltd. | 1997 | — |
| −1 | K022670 | Carraklenz and Ultraklenz | Carrington Laboratories, Inc. | 2002 | — |
| 0 (this device) | K080779 | Irrisept Wound Cleansing System | Irrimax Corporation | 2009 | — |
| +1 | K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020 | — |
| +2 | K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021 | — |
| +1 | K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020 | — |
| +2 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
| +3 | K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K022670 | Carraklenz and UltraklenzSummary page 1…1 CFR 880.5475 Product Code: FQH Legally Marketed MicroKlenzTM Antimicrobial, Deodorizing Wound Cleanser, 510(k) Predicate Devices: #: K022670; DermaGran® Wound Cleanser, 510(k) #s: K970660, K954743, K945802; BioPatch® CHG Dressing, 510(k) #: K… | 2002 |
| * | K970660 | Dermagran Wound Management SystemSummary page 1…Legally Marketed MicroKlenzTM Antimicrobial, Deodorizing Wound Cleanser, 510(k) Predicate Devices: #: K022670; DermaGran® Wound Cleanser, 510(k) #s: K970660, K954743, K945802; BioPatch® CHG Dressing, 510(k) #: K003229 Device Description: IRRISEPTTM Wound… | 1997 |
| * | K954743 | Dermagran Wound Dressing Cleaner W/ZincSummary page 1…nzTM Antimicrobial, Deodorizing Wound Cleanser, 510(k) Predicate Devices: #: K022670; DermaGran® Wound Cleanser, 510(k) #s: K970660, K954743, K945802; BioPatch® CHG Dressing, 510(k) #: K003229 Device Description: IRRISEPTTM Wound Debridement and Cleansing System is… | 1995 |
| * | K945802 | Dermagran Wound Cleanser with ZincSummary page 1…microbial, Deodorizing Wound Cleanser, 510(k) Predicate Devices: #: K022670; DermaGran® Wound Cleanser, 510(k) #s: K970660, K954743, K945802; BioPatch® CHG Dressing, 510(k) #: K003229 Device Description: IRRISEPTTM Wound Debridement and Cleansing System is a manual,… | 1995 |
| * | K003229 | Biopatch Antimicrobial DressingSummary page 1…k) Predicate Devices: #: K022670; DermaGran® Wound Cleanser, 510(k) #s: K970660, K954743, K945802; BioPatch® CHG Dressing, 510(k) #: K003229 Device Description: IRRISEPTTM Wound Debridement and Cleansing System is a manual, self-contained irrigation device with… | 2001 |
What descends from it? (9)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2019 | Class II | Z-0191-2020 | Process control | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. |
| Sep 5, 2017 | Class II | Z-0490-2019 | Other | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K202222 (Irrimax Corporation, 2020) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K022670.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 IRRISEPTTM Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080779: Irrisept Wound Cleansing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080779
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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