FDA applicant

Waters Instruments, Inc.

Rochester, MN12 decisions1981–20060 recalls

FDA records 12 decisions for Waters Instruments, Inc. (Rochester, MN) from 1981 to 2006: 12 510(k) clearances. Most are in product codes DQA (Oximeter) and KDN (System, Perfusion, Kidney). 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 Waters Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Waters Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Waters Instruments, 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 “Waters”

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

Waters Assoc., Inc. 16 Waters Corporation 6 Waters Medical Systems, LLC 3 Waters Chemical Products 2 Waters Chromatography Division 1

Waters Instruments, 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 “Waters”