FDA applicant
Ecolab, Inc.
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
How often FDA has decided Ecolab, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
9in 2015
Class I Class II/III not classified
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.
See the 510(k) Report