FDA applicant

Fenwal, Inc.

Lake Zurich, IL4 decisions1983–20141 recall

FDA records 4 decisions for Fenwal, Inc. (Lake Zurich, IL) from 1983 to 2014: 3 510(k) clearances and 1 original PMA approval. Most are in product codes LKN (Separator, Automated, Blood Cell And Plasma…) and LMN (Ceramics, Calcium Triphosphate/Hydroxypatite…). Its devices cite 5 predicates, 2 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, orthopedic panel, where it files most

How often FDA has decided Fenwal, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Fenwal, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fenwal, Inc.’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 “Fenwal”

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

Fenwal Laboratories 1

Fenwal, Inc.

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 “Fenwal”