Chrysalis Intelligence · Sponsors · Samsung Electronics Co., Ltd.

Samsung Electronics Co., Ltd.

Suwon-Si, KR · 13 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
13
2020-08-04 → 2026-07-31
Last 12 months
2
Product codes
8
Most recent
2026-07-31
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IZL System, X-Ray, Mobile Class II Radiology 3 2024-10-01
QDA Electrocardiograph Software For Over-The-Counter Use Class II Cardiovascular 3 2024-08-02
QZW — — — 2 2026-07-20
SCR Air-Conduction Hearing Aid Software Class II Ear, Nose, Throat 1 2026-07-31
KPR System, X-Ray, Stationary Class II Radiology 1 2024-09-19
PHL — — — 1 2022-04-21
FRA — — — 1 2021-11-26
MYN Analyzer, Medical Image Class II Radiology 1 2021-08-31
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2026-07-31 K261187 Hearing Aid Feature SCR Class II Ear, Nose, Throat
2026-07-20 K261011 Sleep Apnea Feature (v2.0) QZW — —
2024-10-01 K242651 GM85 IZL Class II Radiology
2024-09-19 K242478 GF85 (models GF85-3P, GF85-SP) KPR Class II Radiology
2024-08-02 K240909 Samsung ECG App v 1.3 (ECG) QDA Class II Cardiovascular
2024-02-06 DEN230041 Sleep Apnea Feature QZW — —
2023-05-02 K230292 Samsung ECG Monitor Application with Irregular Heart Rhythm Notification QDA Class II Cardiovascular
2022-09-29 K222353 GM85 IZL Class II Radiology
2022-04-21 K220175 GM85 IZL Class II Radiology
2022-04-21 K213452 GEMS-H PHL — —
2021-11-26 K211139 CUBE Air Purifier FRA — —
2021-08-31 K201560 Auto Lung Nodule Detection MYN Class II Radiology
2020-08-04 K201168 ECG Monitor App QDA Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence