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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 / K253232

510(k) cleared

Seguin Annuloplasty Ring

ABBOTT MEDICAL · Oct 29, 2025 · K253232

FDA cleared the Seguin Annuloplasty Ring from ABBOTT MEDICAL on Oct 29, 2025 under K253232, a special 510(k). The device falls under product code KRH, Ring, Annuloplasty, regulated at 21 CFR 870.3800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 29, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

ABBOTT MEDICAL has 8 other decisions in the tracker over the last 12 months: K262006 (EnSite X EP System), K261825 (Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter), K261631 (Amplatzer TorqVue Exchange System), K253459 (OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)).

Questions & Answers

What did FDA clear under K253232?

K253232 is the FDA 510(k) for Seguin Annuloplasty Ring, submitted by ABBOTT MEDICAL. FDA's decision date was Oct 29, 2025, under product code KRH (Ring, Annuloplasty).

Who makes the Seguin Annuloplasty Ring?

ABBOTT MEDICAL, based in St. Paul, MN, is the applicant of record for K253232.

How long did the K253232 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Oct 29, 2025, 30 days later.

← All decisions in October 2025