FDA applicant

Sutter Biomedical, Inc.

Mchenry, IL11 decisions1981–19880 recalls

FDA records 11 decisions for Sutter Biomedical, Inc. (Mchenry, IL) from 1981 to 1988: 11 510(k) clearances. Most are in product codes BXB (Exerciser, Powered) and KWD (Prosthesis, Toe, Hemi-, Phalangeal). 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Sutter Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sutter Biomedical, Inc.’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 “Sutter”

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

Sutter Medizintechnik GmbH 9 Sutter Corp. 7

Sutter Biomedical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sutter”