FDA applicant

Hutchinson Technology, Inc.

Hutchinson, MN8 decisions1998–20110 recalls

FDA records 8 decisions for Hutchinson Technology, Inc. (Hutchinson, MN) from 1998 to 2011: 8 510(k) clearances. All are in product code MUD (Oximeter, Tissue Saturation). Its devices cite 9 predicates, 9 of them its own earlier devices. 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2011

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hutchinson Technology, 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 “Hutchinson”

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

Hutchinson Sante S.N.C. 1

Hutchinson Technology, 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 “Hutchinson”