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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 / K262548

510(k) cleared

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, LLC · Sep 25, 2026 · K262548

FDA cleared the EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on Sep 25, 2026 under K262548, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 23, 2026. The decision came 64 days later, inside the 90 FDA-day goal for a 510(k).

Philips Ultrasound, LLC has 8 other decisions in the tracker over the last 12 months: K262311 (Alturion Series Diagnostic Ultrasound System), K261211 (Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System), K260667 (Alturion Series Diagnostic Ultrasound System), K260123 (EPIQ Series Diagnostic Ultrasound System).

Questions & Answers

What did FDA clear under K262548?

K262548 is the FDA 510(k) for EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System, submitted by Philips Ultrasound, LLC. FDA's decision date was Sep 25, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?

Philips Ultrasound, LLC, based in Bothell, WA, is the applicant of record for K262548.

How long did the K262548 review take?

FDA received the submission on Jul 23, 2026 and issued its decision on Sep 25, 2026, 64 days later.

← All decisions in September 2026