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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 2025 / K253153

510(k) cleared

SER Pen Carain MicroSystem (MP1209SP)

Su-Ko Technologies, LLC · Oct 29, 2025 · K253153

FDA cleared the SER Pen Carain MicroSystem (MP1209SP) from Su-Ko Technologies, LLC on Oct 29, 2025 under K253153, a special 510(k). The device falls under product code QAI, Powered Microneedle Device, regulated at 21 CFR 878.4430 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 26, 2025. The decision came 33 days later, inside the 90 FDA-day goal for a 510(k).

Su-Ko Technologies, LLC 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 K253153?

K253153 is the FDA 510(k) for SER Pen Carain MicroSystem (MP1209SP), submitted by Su-Ko Technologies, LLC. FDA's decision date was Oct 29, 2025, under product code QAI (Powered Microneedle Device).

Who makes the SER Pen Carain MicroSystem (MP1209SP)?

Su-Ko Technologies, LLC, based in Austin, TX, is the applicant of record for K253153.

How long did the K253153 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Oct 29, 2025, 33 days later.

← All decisions in October 2025