WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / September 2025 / K243910

510(k) cleared

Retraxil

Kulzer, LLC · Sep 24, 2025 · K243910

FDA cleared the Retraxil from Kulzer, LLC on Sep 24, 2025 under K243910, a traditional 510(k). The device falls under product code MVL, Cord, Retraction as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 19, 2024. The decision came 279 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Kulzer, LLC has 2 other decisions in the tracker over the last 12 months: K260783 (Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One), K254063 (iCEM Universal Plus).

Questions & Answers

What did FDA clear under K243910?

K243910 is the FDA 510(k) for Retraxil, submitted by Kulzer, LLC. FDA's decision date was Sep 24, 2025, under product code MVL (Cord, Retraction).

Who makes the Retraxil?

Kulzer, LLC, based in South Bend, IN, is the applicant of record for K243910.

How long did the K243910 review take?

FDA received the submission on Dec 19, 2024 and issued its decision on Sep 24, 2025, 279 days later.

← All decisions in September 2025

Sources