FDA applicant

Excel-Tech Ltd. (Xltek)

Oakville, CA6 decisions2008–20143 recalls

FDA records 6 decisions for Excel-Tech Ltd. (Xltek) (Oakville, CA) from 2008 to 2014: 6 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and OMA (Amplitude-Integrated Electroencephalograph). Its devices cite 5 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

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

How often FDA has decided Excel-Tech Ltd. (Xltek)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2025

2008high 1 (2020) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Excel-Tech Ltd. (Xltek) by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Excel-Tech Ltd. (Xltek)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Excel-Tech”

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

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

Excel-Tech Ltd. (Xltek)

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Excel-Tech”