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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 / October 2026 / K261938

510(k) cleared

APRO 88 Catheter

Alembic, LLC · Oct 6, 2026 · K261938

FDA cleared the APRO 88 Catheter from Alembic, LLC on Oct 6, 2026 under K261938, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 10, 2026. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Alembic, LLC has 2 other decisions in the tracker over the last 12 months: K262391 (APRO 35 Swift Catheter and Alembic Aspiration Tubing), K262392 (APRO 35 Swift Catheter).

Questions & Answers

What did FDA clear under K261938?

K261938 is the FDA 510(k) for APRO 88 Catheter, submitted by Alembic, LLC. FDA's decision date was Oct 6, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the APRO 88 Catheter?

Alembic, LLC, based in Mountain View, CA, is the applicant of record for K261938.

How long did the K261938 review take?

FDA received the submission on Jun 10, 2026 and issued its decision on Oct 6, 2026, 118 days later.

← All decisions in October 2026

Sources