FDA applicant

Waters Medical Systems, LLC

Rochester, MN3 decisions2012–20131 recall

FDA records 3 decisions for Waters Medical Systems, LLC (Rochester, MN) from 2012 to 2013: 3 510(k) clearances. Most are in product codes KDL (Set, Perfusion, Kidney, Disposable) and KDN (System, Perfusion, Kidney). Its devices cite 1 predicate, 0 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, gastroenterology and urology panel, where it files most

How often FDA has decided Waters Medical Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2012high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2022

2012high 1 (2022) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Waters Medical Systems, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 Instruments, Inc. 12 Waters Corporation 6 Waters Chemical Products 2 Waters Chromatography Division 1

Waters Medical Systems, LLC

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 “Waters”