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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K260261

510(k) cleared

Gravity Blood Sets with 200µm Filter

B.Braun Medical, Inc. · Oct 22, 2026 · K260261

FDA cleared the Gravity Blood Sets with 200µm Filter from B.Braun Medical, Inc. on Oct 22, 2026 under K260261, a traditional 510(k). The device falls under product code FPA, Set, Administration, Intravascular, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 28, 2026. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

B.Braun Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K254111 (Irrigation/Urology Sets), K253235 (Introcan Safety® Deep Access XL IV Catheter).

Questions & Answers

What did FDA clear under K260261?

K260261 is the FDA 510(k) for Gravity Blood Sets with 200µm Filter, submitted by B.Braun Medical, Inc.. FDA's decision date was Oct 22, 2026, under product code FPA (Set, Administration, Intravascular).

Who makes the Gravity Blood Sets with 200µm Filter?

B.Braun Medical, Inc., based in Bethlehem, PA, is the applicant of record for K260261.

How long did the K260261 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Oct 22, 2026, 267 days later.

← All decisions in October 2026

Sources