Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Waters Corporation · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
147 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | Waters Corporation | 2007-05-25 | 147 | 0 |
| K980180 | 2700 SAMPLE MANAGER | Waters Corporation | 1998-02-12 | 23 | 0 |
| K973074 | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR | Waters Corporation | 1997-10-06 | 49 | 0 |
| K964588 | WATERS 515 HPLC PUMP (515) | Waters Corporation | 1996-11-29 | 14 | 0 |
| K962574 | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) | Waters Corporation | 1996-07-22 | 21 | 0 |
| K961557 | ALLIANCE 2690 SEPARATIONS MODULE | Waters Corporation | 1996-07-05 | 74 | 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