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Hearing Aid Feature

by Samsung Electronics Co., Ltd

510(k) K261187

Hearing Aid Feature is a Class II device made by Samsung Electronics Co., Ltd, cleared under FDA 510(k) K261187 on 31 Jul 2026, active as of 23 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK261187 Date31 Jul 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
SCR
FDA applicant
Samsung Electronics Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 874.3335
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Devices cleared under K261187

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K261187
UDI-DISize and differences
Hearing Aid Feature V1.0
Samsung Electronics Co., Ltd.
V1.008806099221379 —On the market
Hearing Aid Feature V1.0
Samsung Electronics Co., Ltd.
V1.008806099221355 —On the market

Similar devices

Other devices filed under FDA product code SCR (Air-Conduction Hearing Aid Software).

Other devices from Samsung Electronics Co., Ltd

See all devices from Samsung Electronics Co., Ltd →