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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 / K260250

510(k) cleared

QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)

QT Medical, Inc. · Sep 29, 2026 · K260250

FDA cleared the QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) from QT Medical, Inc. on Sep 29, 2026 under K260250, a traditional 510(k). The device falls under product code DPS, Electrocardiograph, regulated at 21 CFR 870.2340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 27, 2026. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

QT Medical, Inc. has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)), K254260 (The VEGA Cervical Screw System).

Questions & Answers

What did FDA clear under K260250?

K260250 is the FDA 510(k) for QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W), submitted by QT Medical, Inc.. FDA's decision date was Sep 29, 2026, under product code DPS (Electrocardiograph).

Who makes the QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)?

QT Medical, Inc., based in Diamond Bar, CA, is the applicant of record for K260250.

How long did the K260250 review take?

FDA received the submission on Jan 27, 2026 and issued its decision on Sep 29, 2026, 245 days later.

← All decisions in September 2026