Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ecolab, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
273 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filte | Ecolab, Inc. | 2019-03-29 | 231 | 0 |
| K173164 | Ecolab POU Water Filter | Ecolab, Inc. | 2018-06-29 | 273 | 0 |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | Ecolab, Inc. | 2016-01-15 | 134 | 0 |
| K150190 | IntraTemp Solution Warmer | Ecolab, Inc. | 2015-02-26 | 30 | 0 |
| K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | Ecolab, Inc. | 2014-12-30 | 145 | 0 |
| K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH | Ecolab, Inc. | 2014-08-28 | 28 | 9 |
| K883593 | #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY | Ecolab, Inc. | 1988-09-30 | 38 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda