510(k) Report

FDA applicant

Shanghai 3f Electronics Co, Ltd.

Echo, OR2 decisions2010–20120 recalls

FDA records 2 decisions for Shanghai 3f Electronics Co, Ltd. (Echo, OR) from 2010 to 2012: 2 510(k) clearances. All are in product code MWI (Monitor, Physiological, Patient (Without…). Its devices cite 2 predicates, 1 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 3f Electronics Co, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Shanghai 3f Electronics Co, Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai 3f Electronics Co, Ltd.’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?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd. · 20101cites it

What has FDA decided for it lately?

  • K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd. · 2012
  • K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd. · 2010

All 2 as Shanghai 3f Electronics Co, Ltd. →