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The Tracker / March 2026 / K251788

510(k) cleared

Extension tube

Zhuhai DR Medical Instruments Co., Ltd. · Mar 5, 2026 · K251788

FDA cleared the Extension tube from Zhuhai DR Medical Instruments Co., Ltd. on Mar 5, 2026 under K251788, a traditional 510(k). The device falls under product code DXT, Injector And Syringe, Angiographic, regulated at 21 CFR 870.1650 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 11, 2025. The decision came 267 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 Zhuhai DR Medical Instruments Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251788?

K251788 is the FDA 510(k) for Extension tube, submitted by Zhuhai DR Medical Instruments Co., Ltd.. FDA's decision date was Mar 5, 2026, under product code DXT (Injector And Syringe, Angiographic).

Who makes the Extension tube?

Zhuhai DR Medical Instruments Co., Ltd., based in Zhuhai, is the applicant of record for K251788.

How long did the K251788 review take?

FDA received the submission on Jun 11, 2025 and issued its decision on Mar 5, 2026, 267 days later.

← All decisions in March 2026