510(k) Report

FDA applicant

Golden Gate Bio-Device

Castro Valley, CA1 decision1998–19980 recalls

FDA records 1 decision for Golden Gate Bio-Device (Castro Valley, CA) in 1998: 1 510(k) clearance. All are in product code DRX (Electrode, Electrocardiograph). 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 Golden Gate Bio-Device’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Golden Gate Bio-Device since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Golden Gate Bio-Device by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRXElectrode, Electrocardiograph1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K973663Paljet-BGolden Gate Bio-Device · 19981cites it

What has FDA decided for it lately?

  • K973663Paljet-BGolden Gate Bio-Device · 1998

The one decision as Golden Gate Bio-Device →

Other applicant names beginning “Golden”

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

Golden Technologies, Inc. 8Golden Horse Medical Equipment (Wuxi) Co., Ltd. 2Golden Year Supply Co. 2Golden Bonanza Industrial Corp. 1Golden Dental Products, Inc. 1Golden Bridge International, Inc. 1Golden Motor Technology Co., Ltd. 1Golden Charter, Ltd. 1Golden Gloves Intl. 1Golden Vision, Inc. 1Golden Earth Corp. 1Golden State Audiology Assoc. 1