FDA applicant

Western/Scott Fetzer Co.

Westlake, OH1 decision2015–20155 recalls

FDA records 1 decision for Western/Scott Fetzer Co. (Westlake, OH) in 2015: 1 510(k) clearance. All are in product code ECX (Cylinder, Compressed Gas, And Valve). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 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, anesthesiology panel, where it files most

How often FDA has decided Western/Scott Fetzer Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

5in 2019

2015high 5 (2019) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Western/Scott Fetzer Co. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Western/Scott Fetzer Co.’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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Other applicant names beginning “Western/Scott”

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

Western Laboratories Corp. 7 Western Advanced Technology, Inc. 6 Western Medical, Ltd. 4 Western Medical Products, Inc. 3 Western Systems Research, Inc. 2 Western M/D, Inc. 2 Western Surgical Instrument Co. 1 Western Medical Equipment Corp. 1 Western Systems, Inc. 1 The Western Diagnostics Co. 1 Western Medical Research 1 Western Dialysis Supplies, Ltd. 1

Western/Scott Fetzer Co.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Western/Scott”