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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 / K262090

510(k) cleared

Fertilis microICSI Device

Fertilis Pty, Ltd. · Oct 9, 2026 · K262090

FDA cleared the Fertilis microICSI Device from Fertilis Pty, Ltd. on Oct 9, 2026 under K262090, a traditional 510(k). The device falls under product code MQK, Labware, Assisted Reproduction, regulated at 21 CFR 884.6160 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jun 22, 2026. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Fertilis Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262090?

K262090 is the FDA 510(k) for Fertilis microICSI Device, submitted by Fertilis Pty, Ltd.. FDA's decision date was Oct 9, 2026, under product code MQK (Labware, Assisted Reproduction).

Who makes the Fertilis microICSI Device?

Fertilis Pty, Ltd., based in Adelaide, is the applicant of record for K262090.

How long did the K262090 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Oct 9, 2026, 109 days later.

← All decisions in October 2026