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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 / K262621

510(k) cleared

Rapid Barostat Bag (RBB) Pump and Catheter System

Mui Scientific, Inc. · Sep 30, 2026 · K262621

FDA cleared the Rapid Barostat Bag (RBB) Pump and Catheter System from Mui Scientific, Inc. on Sep 30, 2026 under K262621, a special 510(k). The device falls under product code FFX, System, Gastrointestinal Motility (Electrical), regulated at 21 CFR 876.1725 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 28, 2026. The decision came 64 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K262621?

K262621 is the FDA 510(k) for Rapid Barostat Bag (RBB) Pump and Catheter System, submitted by Mui Scientific, Inc.. FDA's decision date was Sep 30, 2026, under product code FFX (System, Gastrointestinal Motility (Electrical)).

Who makes the Rapid Barostat Bag (RBB) Pump and Catheter System?

Mui Scientific, Inc., based in Mississauga, is the applicant of record for K262621.

How long did the K262621 review take?

FDA received the submission on Jul 28, 2026 and issued its decision on Sep 30, 2026, 64 days later.

← All decisions in September 2026