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 / May 2026 / K253642

510(k) cleared

Jada System (Jada-2002)

Organon, LLC · May 15, 2026 · K253642

FDA cleared the Jada System (Jada-2002) from Organon, LLC on May 15, 2026 under K253642, a traditional 510(k). The device falls under product code OQY, Intrauterine Tamponade Balloon, regulated at 21 CFR 884.4530 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Nov 19, 2025. The decision came 177 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 Organon, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253642?

K253642 is the FDA 510(k) for Jada System (Jada-2002), submitted by Organon, LLC. FDA's decision date was May 15, 2026, under product code OQY (Intrauterine Tamponade Balloon).

Who makes the Jada System (Jada-2002)?

Organon, LLC, based in Jersey City, NJ, is the applicant of record for K253642.

How long did the K253642 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on May 15, 2026, 177 days later.

← All decisions in May 2026