# Samsung Electronics Co., Ltd.

- Location (FDA's records): Suwon-Si, KR
- FDA decisions: 43 (2013–2026): 42 510(k) clearances and 1 De Novo grant
- Product codes: KPR (21), IZL (8), MQB (4), QDA (3), QZW (2), PHL (1), FRA (1), MYN (1), DRG (1), SCR (1)
- 510(k) review time since 2016: median 56 days, against 75 for FDA's reviews in the same codes and years (10 of 21 faster)
- Predicates its devices cite: 70 (50 its own); citations of its devices by later devices: 61 (50 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Apple, Inc.: 5 (https://510kreport.com/company/apple)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Fujifilm Medical Systems U.S.A, Inc.: 1 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Carestream Health, Inc.: 1 (https://510kreport.com/company/carestream-health)
- DRGEM Corporation: 1 (https://510kreport.com/company/drgem)
- Honda Motor Company, Ltd.: 1 (https://510kreport.com/company/honda-motor)
- Sedecal., Sa.: 1 (https://510kreport.com/company/sedecal)
- Riverain Technologies, Inc.: 1 (https://510kreport.com/company/riverain-technologies)

## Firms that cite its devices most
- Lg Electronics.Inc: 2 (https://510kreport.com/company/lg-electronics)
- H&abyz Co., Ltd.: 2 (https://510kreport.com/company/h-abyz)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- DRGEM Corporation: 1 (https://510kreport.com/company/drgem)
- Imidex, Inc.: 1 (https://510kreport.com/company/imidex)
- AZmed: 1 (https://510kreport.com/company/azmed)
- Neurologica Corporation, A Subsidiary OF: 1 (https://510kreport.com/company/neurologica-a-subsidiary-of)
- Qure.Ai Technologies: 1 (https://510kreport.com/company/qure-ai-technologies)

## Its most-cited devices
- K181629: GC85A (2018), cited by 5
- K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (2018), cited by 5
- K171119: GM85 (2017), cited by 4
- K150165: GC85A (2015), cited by 3
- K160997: GC85A (2016), cited by 3
- K140334: Xgeo GC80 (2014), cited by 3

## Recent decisions
- K260481: GC85A (Aug 27, 2026)
- K261187: Hearing Aid Feature (Jul 31, 2026)
- K261011: Sleep Apnea Feature (v2.0) (Jul 20, 2026)
- K242651: GM85 (Oct 1, 2024)
- K242478: GF85 (models GF85-3P, GF85-SP) (Sep 19, 2024)
- K240909: Samsung ECG App v 1.3 (ECG) (Aug 2, 2024)
- DEN230041: Sleep Apnea Feature (Feb 6, 2024)
- K230292: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (May 2, 2023)

Source page: https://510kreport.com/company/samsung-electronics