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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / September 2026 / K262893

510(k) cleared

Eonis SMA kit

Revvity, Inc. · Sep 30, 2026 · K262893

FDA cleared the Eonis SMA kit from Revvity, Inc. on Sep 30, 2026 under K262893, a traditional 510(k). The device falls under product code QUE, Spinal Muscular Atrophy Newborn Screening Test System, regulated at 21 CFR 866.5980 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Aug 17, 2026. The decision came 44 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K262893?

K262893 is the FDA 510(k) for Eonis SMA kit, submitted by Revvity, Inc.. FDA's decision date was Sep 30, 2026, under product code QUE (Spinal Muscular Atrophy Newborn Screening Test System).

Who makes the Eonis SMA kit?

Revvity, Inc., based in Waltham, MA, is the applicant of record for K262893.

How long did the K262893 review take?

FDA received the submission on Aug 17, 2026 and issued its decision on Sep 30, 2026, 44 days later.

← All decisions in September 2026