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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 / January 2026 / K254126

510(k) cleared

Natrelle 133S Tissue Expanders

AbbVie · Jan 16, 2026 · K254126

FDA cleared the Natrelle 133S Tissue Expanders from AbbVie on Jan 16, 2026 under K254126, a special 510(k). The device falls under product code LCJ, Tissue Expander And Accessories as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 19, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for AbbVie in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254126?

K254126 is the FDA 510(k) for Natrelle 133S Tissue Expanders, submitted by AbbVie. FDA's decision date was Jan 16, 2026, under product code LCJ (Tissue Expander And Accessories).

Who makes the Natrelle 133S Tissue Expanders?

AbbVie, based in Irvine, CA, is the applicant of record for K254126.

How long did the K254126 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Jan 16, 2026, 28 days later.

← All decisions in January 2026