FDA Clears BD's Surgiphor 1000mL Wound Irrigation System for Powered Lavage
The larger bottle of BD's povidone-iodine irrigation solution comes with fittings for powered lavage devices used in operating rooms.
The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- The FDA cleared the BD Surgiphor 1000 mL Antimicrobial Irrigation System under 510(k) K253445 on February 20, 2026; BD announced it on March 2.
- The 510(k) summary says the solution and intended use are unchanged from the earlier Surgiphor system; the new version adds a 1000 mL bottle and parts for powered lavage.
- The cleared indication is to mechanically loosen and remove debris and foreign materials, including microorganisms, from wounds.
The US Food and Drug Administration has cleared a 1000 mL version of BD's Surgiphor antimicrobial irrigation system, a ready-to-use povidone-iodine solution for washing surgical wounds that can now be connected to powered lavage devices, the company announced on March 2.
The FDA's 510(k) database lists the clearance as K253445 for the BD Surgiphor 1000 mL Antimicrobial Irrigation System. The agency received the traditional 510(k) on October 2, 2025, and found the device substantially equivalent on February 20, 2026. It is classed as a jet lavage device and was reviewed by the general and plastic surgery panel.
Same solution, bigger bottle
According to the clearance letter and 510(k) summary, the device is a terminally sterilized 1000 mL bottle of Surgiphor solution, which is 0.5% povidone-iodine, packed with a screw cap for manual irrigation and an adaptor and Y-connector for powered irrigation. The powered lavage device itself is not included.
The cleared indication says the system "is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds." The summary explains that the mechanical action of fluid moving across the wound is the mechanism of action, and that the povidone-iodine serves as a preservative so that no microbial growth occurs in the solution once the bottle is open.
The predicate is BD's own earlier Surgiphor Antimicrobial Irrigation System, cleared as K221504, which comes in a 450 mL bottle. The summary says the new version is unchanged from that device in intended use, solution composition and primary mechanism of action, and that the new configuration needed new packaging. Testing listed for the change includes biocompatibility, endotoxin and sterilization work.
BD's announcement notes that the product is "Not indicated for use as an antimicrobial at or within the wound site."
What BD says
BD described the Surgiphor 1000mL as the "first and only 1000 mL antimicrobial irrigation system specifically designed for powered lavage." That is the company's own characterization. It said the product arrives sterile and ready to use, so hospital staff do not need to mix solutions by hand.
The release lists features including compatibility with many commonly used powered lavage devices, a Y-connector for switching between saline and Surgiphor solution, integrated venting and a collapsible bottle.
"This FDA clearance reinforces BD's position as the global leader in surgical irrigation innovation," said Rian Seger, worldwide president of the BD Surgery business, in the release.
BD said the expanded Surgiphor portfolio now offers both manual and powered irrigation configurations. The company did not disclose pricing or a launch date in the release.
Sources
- BD Pioneers New Standard in Surgical Safety with FDA-Cleared Surgiphor 1000mL for Wound Irrigation, BD, March 2, 2026
- 510(k) K253445: BD Surgiphor 1000 mL Antimicrobial Irrigation System (database record), US Food and Drug Administration, February 20, 2026
- K253445 clearance letter and 510(k) summary, US Food and Drug Administration, February 20, 2026