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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 / K260140

510(k) cleared

Aevice Wheeze Detection Module

Aevice Health Pte. , Ltd. · Sep 25, 2026 · K260140

FDA cleared the Aevice Wheeze Detection Module from Aevice Health Pte. , Ltd. on Sep 25, 2026 under K260140, a traditional 510(k). The device falls under product code PHZ, Abnormal Breath Sound Device, regulated at 21 CFR 868.1900 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jan 20, 2026. The decision came 248 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 Aevice Health Pte. , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260140?

K260140 is the FDA 510(k) for Aevice Wheeze Detection Module, submitted by Aevice Health Pte. , Ltd.. FDA's decision date was Sep 25, 2026, under product code PHZ (Abnormal Breath Sound Device).

Who makes the Aevice Wheeze Detection Module?

Aevice Health Pte. , Ltd., based in Singapore, is the applicant of record for K260140.

How long did the K260140 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Sep 25, 2026, 248 days later.

← All decisions in September 2026