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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 / May 2026 / K253112

510(k) cleared

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

Hlb Lifescience Co., Ltd. · May 21, 2026 · K253112

FDA cleared the Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) from Hlb Lifescience Co., Ltd. on May 21, 2026 under K253112, a special 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 24, 2025. The decision came 239 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 Hlb Lifescience Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253112?

K253112 is the FDA 510(k) for Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe), submitted by Hlb Lifescience Co., Ltd.. FDA's decision date was May 21, 2026, under product code FMF (Syringe, Piston).

Who makes the Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)?

Hlb Lifescience Co., Ltd., based in Anseong-Si, is the applicant of record for K253112.

How long did the K253112 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on May 21, 2026, 239 days later.

← All decisions in May 2026