510(k) Report

FDA applicant

Ecolab, Inc.

Saint Paul, MN7 decisions1988–20199 recalls

FDA records 7 decisions for Ecolab, Inc. (Saint Paul, MN) from 1988 to 2019: 7 510(k) clearances. Most are in product codes LHC (Warmer, Irrigation Solution) and NHV (System, Water Purification, General Medical Use). Its devices cite 8 predicates, 1 of them its own earlier devices. 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

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

FDA decisions per year

1in 2019

2014: 22015: 12016: 12018: 12019: 1
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

9in 2015

2015: 9
2007high 9 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ecolab, 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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