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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 / February 2026 / K253354

510(k) cleared

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

Guangzhou Hehong Biotech Co., Ltd. · Feb 12, 2026 · K253354

FDA cleared the Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) from Guangzhou Hehong Biotech Co., Ltd. on Feb 12, 2026 under K253354, a traditional 510(k). The device falls under product code MQF, Catheter, Assisted Reproduction, regulated at 21 CFR 884.6110 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Sep 30, 2025. The decision came 135 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 Guangzhou Hehong Biotech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253354?

K253354 is the FDA 510(k) for Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C), submitted by Guangzhou Hehong Biotech Co., Ltd.. FDA's decision date was Feb 12, 2026, under product code MQF (Catheter, Assisted Reproduction).

Who makes the Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)?

Guangzhou Hehong Biotech Co., Ltd., based in Guangzhou, is the applicant of record for K253354.

How long did the K253354 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Feb 12, 2026, 135 days later.

← All decisions in February 2026