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THE TAPE

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 / K260215

510(k) cleared

BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)

Bd Biosciences · Oct 20, 2026 · K260215

FDA cleared the BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) from Bd Biosciences on Oct 20, 2026 under K260215, a traditional 510(k). The device falls under product code OYE, Flow Cytometric Reagents And Accessories., regulated at 21 CFR 864.5220 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Jan 23, 2026. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bd Biosciences in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260215?

K260215 is the FDA 510(k) for BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5), submitted by Bd Biosciences. FDA's decision date was Oct 20, 2026, under product code OYE (Flow Cytometric Reagents And Accessories.).

Who makes the BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)?

Bd Biosciences, based in Milpitas, CA, is the applicant of record for K260215.

How long did the K260215 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Oct 20, 2026, 270 days later.

← All decisions in October 2026