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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 / March 2026 / K253863

510(k) cleared

GUARDIAN Quick Dip Residual Chlorine (5212)

Serim Research · Mar 17, 2026 · K253863

FDA cleared the GUARDIAN Quick Dip Residual Chlorine (5212) from Serim Research on Mar 17, 2026 under K253863, a traditional 510(k). The device falls under product code FKJ, Filter, Blood, Dialysis, regulated at 21 CFR 876.5820 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 3, 2025. The decision came 104 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 Serim Research in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253863?

K253863 is the FDA 510(k) for GUARDIAN Quick Dip Residual Chlorine (5212), submitted by Serim Research. FDA's decision date was Mar 17, 2026, under product code FKJ (Filter, Blood, Dialysis).

Who makes the GUARDIAN Quick Dip Residual Chlorine (5212)?

Serim Research, based in Elkhart, IN, is the applicant of record for K253863.

How long did the K253863 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Mar 17, 2026, 104 days later.

← All decisions in March 2026