Ecolab, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ecolab, Inc.” (first 1988, latest 2019), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 134 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 86 |
| 2015 | 1 | 30 |
| 2016 | 1 | 134 |
| 2017 | 0 | — |
| 2018 | 1 | 273 |
| 2019 | 1 | 231 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ecolab, Inc. took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LHC | Warmer, Irrigation Solution | 4 | 4 |
| NHV | System, Water Purification, General Medical Use | 2 | 2 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
Review panels
Most recent Ecolab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand | NHV | 2019-03-29 | 231 |
| K173164 | Ecolab POU Water Filter | NHV | 2018-06-29 | 273 |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | LHC | 2016-01-15 | 134 |
| K150190 | IntraTemp Solution Warmer | LHC | 2015-02-26 | 30 |
| K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | LHC | 2014-12-30 | 145 |
| K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED | LHC | 2014-08-28 | 28 |
| K883593 | #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY | CAE | 1988-09-30 | 38 |
Recalls
17 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2021-01-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
ECOLAB INC. (ECL): EDGAR filings, CIK 31462. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ecolab, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Ecolab, Inc.” (first 1988, latest 2019), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ecolab, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ecolab, Inc. is 134 days.
Which FDA product codes appear under Ecolab, Inc.?
The most frequent FDA product codes under this applicant name are LHC (Warmer, Irrigation Solution, 4); NHV (System, Water Purification, General Medical Use, 2); CAE (Airway, Oropharyngeal, Anesthesiology, 1).
Next steps
- See all 7 Ecolab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LHC, Ecolab, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.