Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Better Water, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051620 | MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL | Better Water, Inc. | 2005-11-18 | 154 | 0 |
| K992793 | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRA | Better Water, Inc. | 1999-11-16 | 89 | 0 |
| K954928 | PORTABLE REVERSE OSMOSIS MACHINE | Better Water, Inc. | 1996-01-24 | 90 | 0 |
| K920186 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Better Water, Inc. | 1995-06-13 | 1246 | 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