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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262215

510(k) cleared

Profoject Safety Sliding Blood Collection Set

CMT Health PTE., Ltd. · Sep 25, 2026 · K262215

FDA cleared the Profoject Safety Sliding Blood Collection Set from CMT Health PTE., Ltd. on Sep 25, 2026 under K262215, a traditional 510(k). The device falls under product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection, regulated at 21 CFR 862.1675 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jun 30, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

CMT Health PTE., Ltd. has 8 other decisions in the tracker over the last 12 months: K261372 (Profoject LOR Syringe), K261829 (Profoject Dual-Safety Pen Needles), K260739 (Profoject Pen Needles (Model A; Model B)), K260514 (Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle).

Questions & Answers

What did FDA clear under K262215?

K262215 is the FDA 510(k) for Profoject Safety Sliding Blood Collection Set, submitted by CMT Health PTE., Ltd.. FDA's decision date was Sep 25, 2026, under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

Who makes the Profoject Safety Sliding Blood Collection Set?

CMT Health PTE., Ltd., based in Singapore, is the applicant of record for K262215.

How long did the K262215 review take?

FDA received the submission on Jun 30, 2026 and issued its decision on Sep 25, 2026, 87 days later.

← All decisions in September 2026