510(k) · Cleared
ClearedBD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Feb 20, 2026 as substantially equivalent to K221504 (Bd, 2022) after a 141-day review. Its family tree reaches back 14 generations to 1992.
- Decided
- Feb 20, 2026
- Review
- 141 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K914579 (1992). 58 ancestors in all, the oldest K830708 (1983). No later device cites it as a predicate yet.
- Root · 14 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 10 generations between
- 3 generations backK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- 2 generations backK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
- 1 generation backK221504 BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022
- This deviceK253445 BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
Show all 14 generations
- Root · 14 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 13 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 12 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 11 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 10 generations backK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- 9 generations backK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- 8 generations backK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- 7 generations backK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- 6 generations backK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
- 5 generations backK133542 Puracyn Plus Skin and WoundInnovacyn, Inc. · 2014
- 4 generations backK181428 Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc. · 2019
- 3 generations backK202071 SURGIPHOR Wound Irrigation SystemOrthophor, LLC · 2020
- 2 generations backK213616 BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company · 2022
- 1 generation backK221504 BD Surgiphor™ Antimicrobial Irrigation SystemBd · 2022
- This deviceK253445 BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −13 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −12 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −11 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −10 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| −9 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| −8 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| −7 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| −6 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
| −5 | K133542 | Puracyn Plus Skin and Wound | Innovacyn, Inc. | 2014 | — |
| −4 | K181428 | Clyra Wound Irrigation Solution | Clyra Medical Technologies, Inc. | 2019 | — |
| −3 | K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020 | — |
| −2 | K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022 | — |
| −1 | K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K221504 | BD Surgiphor™ Antimicrobial Irrigation SystemSummary page 5…Wound, Drug); Class II (21 CFR 880.5475) Applicant: Becton, Dickinson and Company (BD) K221504 Page 1 of 6… | 2022 |
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 34 years and passes through 12 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 58 ancestors have a recall of any class.
- 1 other device also cites its predicate K221504.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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™ 1000 mL Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253445: BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253445
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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