510(k) Report

FDA applicant

Excel Medical Electronics, LLC

Jupiter, FL1 decision2018–20180 recalls

FDA records 1 decision for Excel Medical Electronics, LLC (Jupiter, FL) in 2018: 1 510(k) clearance. All are in product code MWI (Monitor, Physiological, Patient (Without…). 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 Excel Medical Electronics, LLC’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 — Excel Medical Electronics, LLC 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?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

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

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.

  • K171056WAVE Clinical PlatformExcel Medical Electronics, LLC · 20181cites it

What has FDA decided for it lately?

  • K171056WAVE Clinical PlatformExcel Medical Electronics, LLC · 2018

The one decision as Excel Medical Electronics, LLC →

Other applicant names beginning “Excel”

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

Excel Tech., Ltd. 58Excel Scientific, Inc. 8Excel-Tech Ltd. (Xltek) 6Excel Medical, Inc. 5Excel Health Care Products 5Excel U.S.A. 3Excel Mobility Products, Inc. 2Excel Medical Products, Inc. 2Excel Rubber Products (M) Sdn. Bhd. 1Excel Porcelain Products 1Excel Glove Co., Ltd. 1Excel Medical Systems, Inc. 1