Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MTW · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011598 | WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE | Irvine Scientific Sales Co., Inc. | 2001-06-13 | 20 | 0 |
| K993140 | WATER FOR TISSUE CULTURE, MODELS 1500 | Conception Technologies | 2000-08-02 | 317 | 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