510(k) · Cleared
ClearedBD Surgiphor Antimicrobial Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · FQH Lavage, Jet
Cleared on Mar 23, 2022 as substantially equivalent to K210536 (Irrimax Corporation, 2021) and 1 other predicate after a 128-day review. Its family tree reaches back 12 generations to 1992. 3 later devices descend from it.
- Decided
- Mar 23, 2022
- Review
- 128 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K914579 (1992). 56 ancestors in all, the oldest K830708 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 8 generations between
- 3 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 2 generations backK181428 Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019
- 1 generation backK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- This deviceK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
- Descendant · cites it directly · 2 of its ownK221504 BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022
- Descendant · 2 generations on · 0 of its ownK253996 BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
- Descendant · 2 generations on · 0 of its ownK253445 BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
Show all 12 generations
- Root · 12 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 11 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 10 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 9 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 8 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 7 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 6 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 5 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 4 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 3 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 2 generations backK181428 Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019
- 1 generation backK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- This deviceK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
Most influential descendants
Showing 3 of 3 · See all- K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022 · cites it directly2descendants
- K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026 · 2 generations on0descendants
- K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −11 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −10 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −9 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −8 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −7 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −6 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −5 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −4 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −3 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| −2 | K181428 | Clyra Wound Irrigation Solution | Clyra Medical Technologies, Inc. | 2019 | — |
| −1 | K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020 | — |
| 0 (this device) | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
| +1 | K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022 | — |
| +2 | K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026 | — |
| +2 | K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K210536 | Irrisept Antimicrobial Wound LavageSummary page 4…sing, Wound, Drug); Unclassified (pre-amendment) Applicant: Irrimax Corporation K210536 Secondary Predicate Device: Surgiphor™ Wound Irrigation System Product Code: FQH (Jet Lavage); C… | 2021 |
| * | K202071 | SURGIPHOR Wound Irrigation SystemSummary page 4…uct Code: FQH (Jet Lavage); Class II (21 CFR 880.5475) Applicant: Orthophor LLC K202071 Reference Device: Atteris Antimicrobial Skin and Wound Cleanser Product Code: FRO (Dre… | 2020 |
| † | K160192 | Atteris Antimicrobial Skin & Wound Cleanser | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221504 | BD Surgiphor™ Antimicrobial Irrigation System | 2022 | 2 |
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 30 years and passes through 11 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 56 ancestors have a recall of any class.
- Of its descendants, K221504 (Bd, 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K210536.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
BD Surgiphor ™ Antimicrobial Irrigation System is intended to mechanicallly loosen and remove debris, and foreign materials, including microorganisms, from wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213616: BD Surgiphor Antimicrobial Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213616
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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