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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

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