510(k) Report

FDA applicant

Mcewen and Associates Consulting, Ltd.

Vancouver, CA1 decision2021–20211 recall

FDA records 1 decision for Mcewen and Associates Consulting, Ltd. (Vancouver, CA) in 2021: 1 510(k) clearance. All are in product code KCY (Tourniquet, Pneumatic). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Mcewen and Associates Consulting, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2021high 1 (2025) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Mcewen and Associates Consulting, Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mcewen and Associates Consulting, 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?

  • KCYTourniquet, Pneumatic1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting, Ltd. · 20211 recall

The one decision as Mcewen and Associates Consulting, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K202919Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems…Dec 24, 2025Class II