510(k) Report

FDA applicant

Shanghai Intco Electrode Manufacturing Co., Ltd.

Sandpoint, ID2 decisions2004–20100 recalls

FDA records 2 decisions for Shanghai Intco Electrode Manufacturing Co., Ltd. (Sandpoint, ID) from 2004 to 2010: 2 510(k) clearances. All are in product code DRX (Electrode, Electrocardiograph). Its devices cite 3 predicates, 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 Shanghai Intco Electrode Manufacturing Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Intco Electrode Manufacturing Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Intco Electrode Manufacturing…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DRXElectrode, Electrocardiograph2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K093327Intco Tab ElectrodeShanghai Intco Electrode Manufacturing Co., Ltd. · 2010
  • K041954Disposable Monitoring ElectrodesShanghai Intco Electrode Manufacturing Co., Ltd. · 2004

All 2 as Shanghai Intco Electrode Manufacturing Co., Ltd. →