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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 / K262299

510(k) cleared

Instant-View® hCG Combo II Cassette Test

Alfa Scientific Designs, Inc. · Sep 22, 2026 · K262299

FDA cleared the Instant-View® hCG Combo II Cassette Test from Alfa Scientific Designs, Inc. on Sep 22, 2026 under K262299, a traditional 510(k). The device falls under product code JHI, Visual, Pregnancy Hcg, Prescription Use, regulated at 21 CFR 862.1155 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jul 7, 2026. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Alfa Scientific Designs, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262299?

K262299 is the FDA 510(k) for Instant-View® hCG Combo II Cassette Test, submitted by Alfa Scientific Designs, Inc.. FDA's decision date was Sep 22, 2026, under product code JHI (Visual, Pregnancy Hcg, Prescription Use).

Who makes the Instant-View® hCG Combo II Cassette Test?

Alfa Scientific Designs, Inc., based in Powat, CA, is the applicant of record for K262299.

How long did the K262299 review take?

FDA received the submission on Jul 7, 2026 and issued its decision on Sep 22, 2026, 77 days later.

← All decisions in September 2026