WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / February 2026 / K253445

510(k) cleared

BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)

Bd · Feb 20, 2026 · K253445

FDA cleared the BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) from Bd on Feb 20, 2026 under K253445, a traditional 510(k). The device falls under product code FQH, Lavage, Jet, regulated at 21 CFR 880.5475 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Oct 2, 2025. The decision came 141 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bd has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K253445?

K253445 is the FDA 510(k) for BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120), submitted by Bd. FDA's decision date was Feb 20, 2026, under product code FQH (Lavage, Jet).

Who makes the BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)?

Bd, based in Vernon Hills, IL, is the applicant of record for K253445.

How long did the K253445 review take?

FDA received the submission on Oct 2, 2025 and issued its decision on Feb 20, 2026, 141 days later.

← All decisions in February 2026