FDA applicant

Waters Assoc., Inc.

Mchenry, IL16 decisions1976–19810 recalls

FDA records 16 decisions for Waters Assoc., Inc. (Mchenry, IL) from 1976 to 1981: 16 510(k) clearances. Most are in product codes KIE (Apparatus, High Pressure Liquid Chromatography) and DXG (Computer, Diagnostic, Pre-Programmed…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Waters Assoc., 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 “Waters”

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

Waters Instruments, Inc. 12 Waters Corporation 6 Waters Medical Systems, LLC 3 Waters Chemical Products 2 Waters Chromatography Division 1

Waters Assoc., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Waters”