WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / K254058

510(k) cleared

DistaSense(TM) (v1)

Life Detection Technologies · Sep 25, 2026 · K254058

FDA cleared the DistaSense(TM) (v1) from Life Detection Technologies on Sep 25, 2026 under K254058, a traditional 510(k). The device falls under product code DRT, Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 17, 2025. The decision came 282 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 Life Detection Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254058?

K254058 is the FDA 510(k) for DistaSense(TM) (v1), submitted by Life Detection Technologies. FDA's decision date was Sep 25, 2026, under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)).

Who makes the DistaSense(TM) (v1)?

Life Detection Technologies, based in Sunnyvale, CA, is the applicant of record for K254058.

How long did the K254058 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Sep 25, 2026, 282 days later.

← All decisions in September 2026