Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dayton Water Systems · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021352 | DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR H | Dayton Water Systems | 2002-08-01 | 94 | 0 |
| K981680 | ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS | Dayton Water Systems | 1998-12-31 | 232 | 0 |
| K924695 | ASEPTECH PORTABLE RO+ SYSTEM | Dayton Water Systems | 1995-08-24 | 1071 | 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