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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 / April 2026 / K260839

510(k) cleared

Protaryx Transseptal Puncture Device (PTX2-001)

Protaryx Medical, Inc. · Apr 10, 2026 · K260839 · In the directory

FDA cleared the Protaryx Transseptal Puncture Device (PTX2-001) from Protaryx Medical, Inc. on Apr 10, 2026 under K260839, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 13, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260839?

K260839 is the FDA 510(k) for Protaryx Transseptal Puncture Device (PTX2-001), submitted by Protaryx Medical, Inc.. FDA's decision date was Apr 10, 2026, under product code DYB (Introducer, Catheter).

Who makes the Protaryx Transseptal Puncture Device (PTX2-001)?

Protaryx Medical, Inc., based in Baltimore, MD, is the applicant of record for K260839. The company is listed in the MedDevice Startups directory.

How long did the K260839 review take?

FDA received the submission on Mar 13, 2026 and issued its decision on Apr 10, 2026, 28 days later.

← All decisions in April 2026

Sources

In the startup directory

Protaryx Medical

Cardiovascular · Baltimore, MD