Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scitech Solutions, 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) |
|---|---|---|---|---|---|
| K982009 | ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE | Scitech Solutions, Inc. | 1998-06-25 | 84 | 0 |
| K973996 | CLEARLINE PLUS, DENTAL WATERLINE FILTER | Scitech Solutions, Inc. | 1998-02-04 | 106 | 0 |
| K960556 | BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE | Scitech Solutions, Inc. | 1996-05-08 | 89 | 0 |
| K930144 | THE SCITECH ONE-DAY FILTER | Scitech Solutions, Inc. | 1994-02-22 | 406 | 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