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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 / K251888

510(k) cleared

VPAP Pediatric Face Mask

Hsiner Co., Ltd. · Mar 12, 2026 · K251888

FDA cleared the VPAP Pediatric Face Mask from Hsiner Co., Ltd. on Mar 12, 2026 under K251888, a traditional 510(k). The device falls under product code CBK, Ventilator, Continuous, Facility Use, regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jun 20, 2025. The decision came 265 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 Hsiner Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251888?

K251888 is the FDA 510(k) for VPAP Pediatric Face Mask, submitted by Hsiner Co., Ltd.. FDA's decision date was Mar 12, 2026, under product code CBK (Ventilator, Continuous, Facility Use).

Who makes the VPAP Pediatric Face Mask?

Hsiner Co., Ltd., based in Taichung City, is the applicant of record for K251888.

How long did the K251888 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Mar 12, 2026, 265 days later.

← All decisions in March 2026