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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 / July 2026 / K261187

510(k) cleared

Hearing Aid Feature

Samsung Electronics Co., Ltd. · Jul 31, 2026 · K261187

FDA cleared the Hearing Aid Feature from Samsung Electronics Co., Ltd. on Jul 31, 2026 under K261187, a traditional 510(k). The device falls under product code SCR, Air-Conduction Hearing Aid Software, regulated at 21 CFR 874.3335 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Apr 10, 2026. The decision came 112 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Samsung Electronics Co., Ltd. has one other decision in the tracker over the last 12 months: K261011 (Sleep Apnea Feature (v2.0)).

Questions & Answers

What did FDA clear under K261187?

K261187 is the FDA 510(k) for Hearing Aid Feature, submitted by Samsung Electronics Co., Ltd.. FDA's decision date was Jul 31, 2026, under product code SCR (Air-Conduction Hearing Aid Software).

Who makes the Hearing Aid Feature?

Samsung Electronics Co., Ltd., based in Suwon-Si, is the applicant of record for K261187.

How long did the K261187 review take?

FDA received the submission on Apr 10, 2026 and issued its decision on Jul 31, 2026, 112 days later.

← All decisions in July 2026

Sources