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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 / K251178

510(k) cleared

Ready to use Nelaton Catheter

Jamjoom Fullcare Corporation · Jan 2, 2026 · K251178

FDA cleared the Ready to use Nelaton Catheter from Jamjoom Fullcare Corporation on Jan 2, 2026 under K251178, a traditional 510(k). The device falls under product code EZD, Catheter, Straight, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 16, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Jamjoom Fullcare Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251178?

K251178 is the FDA 510(k) for Ready to use Nelaton Catheter, submitted by Jamjoom Fullcare Corporation. FDA's decision date was Jan 2, 2026, under product code EZD (Catheter, Straight).

Who makes the Ready to use Nelaton Catheter?

Jamjoom Fullcare Corporation, based in Shaoxing, is the applicant of record for K251178.

How long did the K251178 review take?

FDA received the submission on Apr 16, 2025 and issued its decision on Jan 2, 2026, 261 days later.

← All decisions in January 2026