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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 / K252537

510(k) cleared

Rusch SoftSimplastic Foley Catheters

Teleflex Medical Sdn. Bhd. · Jan 20, 2026 · K252537

FDA cleared the Rusch SoftSimplastic Foley Catheters from Teleflex Medical Sdn. Bhd. on Jan 20, 2026 under K252537, a traditional 510(k). The device falls under product code EZL, Catheter, Retention Type, Balloon, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 12, 2025. The decision came 161 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Teleflex Medical Sdn. Bhd. has 2 other decisions in the tracker over the last 12 months: K262056 (Rusch Latex Gold Foley Catheter), K252643 (Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled).

Questions & Answers

What did FDA clear under K252537?

K252537 is the FDA 510(k) for Rusch SoftSimplastic Foley Catheters, submitted by Teleflex Medical Sdn. Bhd.. FDA's decision date was Jan 20, 2026, under product code EZL (Catheter, Retention Type, Balloon).

Who makes the Rusch SoftSimplastic Foley Catheters?

Teleflex Medical Sdn. Bhd., based in Kamunting, is the applicant of record for K252537.

How long did the K252537 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Jan 20, 2026, 161 days later.

← All decisions in January 2026

Sources