510(k) Report

FDA applicant

Samsung Strategy and Innovation Center (Ssic)

San Jose, CA1 decision2018–20180 recalls

FDA records 1 decision for Samsung Strategy and Innovation Center (Ssic) (San Jose, CA) in 2018: 1 510(k) clearance. All are in product code DPS (Electrocardiograph). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Samsung Strategy and Innovation Center (Ssic)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Samsung Strategy and Innovation Center (Ssic) by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DPSElectrocardiograph1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K181998CardioBand ECG Event RecorderSamsung Strategy and Innovation Center (Ssic) · 2018

The one decision as Samsung Strategy and Innovation Center (Ssic) →

Other applicant names beginning “Samsung”

FDA records each applicant name separately; these may or may not be the same firm.

Samsung Medison Co., Ltd. 75Samsung Electronics Co., Ltd. 43Samsung Sds Co., Ltd. 6Samsung Mobile Display Co., Ltd. 5Samsung HME America, Inc., dba NeuroLogica Corp. 1