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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 / K260214

510(k) cleared

STA® - Liquid Anti-Xa

Diagnostica Stago, Inc. · Sep 24, 2026 · K260214

FDA cleared the STA® - Liquid Anti-Xa from Diagnostica Stago, Inc. on Sep 24, 2026 under K260214, a special 510(k). The device falls under product code KFF, Assay, Heparin, regulated at 21 CFR 864.7525 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Jan 23, 2026. The decision came 244 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Diagnostica Stago, Inc. has one other decision in the tracker over the last 12 months: K253658 (STA Satellite Max®).

Questions & Answers

What did FDA clear under K260214?

K260214 is the FDA 510(k) for STA® - Liquid Anti-Xa, submitted by Diagnostica Stago, Inc.. FDA's decision date was Sep 24, 2026, under product code KFF (Assay, Heparin).

Who makes the STA® - Liquid Anti-Xa?

Diagnostica Stago, Inc., based in Parsippany, NJ, is the applicant of record for K260214.

How long did the K260214 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Sep 24, 2026, 244 days later.

← All decisions in September 2026

Sources