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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 / July 2026 / K253667

510(k) cleared

Accoat Guide Wire

Sp Medical A/S · Jul 14, 2026 · K253667

FDA cleared the Accoat Guide Wire from Sp Medical A/S on Jul 14, 2026 under K253667, a traditional 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 21, 2025. The decision came 235 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sp Medical A/S has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K253667?

K253667 is the FDA 510(k) for Accoat Guide Wire, submitted by Sp Medical A/S. FDA's decision date was Jul 14, 2026, under product code DQX (Wire, Guide, Catheter).

Who makes the Accoat Guide Wire?

Sp Medical A/S, based in Karise, is the applicant of record for K253667.

How long did the K253667 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Jul 14, 2026, 235 days later.

← All decisions in July 2026