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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 / April 2026 / K252318

510(k) cleared

Insufflator (OPTO-IFL1000)

Guangdong Optomedic Technologies, Inc. · Apr 16, 2026 · K252318

FDA cleared the Insufflator (OPTO-IFL1000) from Guangdong Optomedic Technologies, Inc. on Apr 16, 2026 under K252318, a traditional 510(k). The device falls under product code HIF, Insufflator, Laparoscopic, regulated at 21 CFR 884.1730 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jul 25, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guangdong Optomedic Technologies, Inc. has one other decision in the tracker over the last 12 months: K252697 (3D Laparoscope).

Questions & Answers

What did FDA clear under K252318?

K252318 is the FDA 510(k) for Insufflator (OPTO-IFL1000), submitted by Guangdong Optomedic Technologies, Inc.. FDA's decision date was Apr 16, 2026, under product code HIF (Insufflator, Laparoscopic).

Who makes the Insufflator (OPTO-IFL1000)?

Guangdong Optomedic Technologies, Inc., based in Foshan, is the applicant of record for K252318.

How long did the K252318 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Apr 16, 2026, 265 days later.

← All decisions in April 2026

Sources