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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 / K261234

510(k) cleared

The D-Tip Denudation Pipette

Allwin Medical Devices, Inc. · Oct 9, 2026 · K261234

FDA cleared the The D-Tip Denudation Pipette from Allwin Medical Devices, Inc. on Oct 9, 2026 under K261234, a traditional 510(k). The device falls under product code MQH, Microtools, Assisted Reproduction (Pipettes), regulated at 21 CFR 884.6130 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Apr 15, 2026. The decision came 177 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 Allwin Medical Devices, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261234?

K261234 is the FDA 510(k) for The D-Tip Denudation Pipette, submitted by Allwin Medical Devices, Inc.. FDA's decision date was Oct 9, 2026, under product code MQH (Microtools, Assisted Reproduction (Pipettes)).

Who makes the The D-Tip Denudation Pipette?

Allwin Medical Devices, Inc., based in Anaheim, CA, is the applicant of record for K261234.

How long did the K261234 review take?

FDA received the submission on Apr 15, 2026 and issued its decision on Oct 9, 2026, 177 days later.

← All decisions in October 2026