Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GJW · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896670 | TIP TOP(R) DISPENSER CAPS | Helena Laboratories | 1990-03-23 | 116 | 0 |
| K771137 | PIPETS UNIFORM DROP SIZE BOROSILICATE | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 | 41 | 0 |
| K771138 | PIPETS BOROSILICATE GLASS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 | 41 | 0 |
| K760899 | STERILE DISPOSABLE COTTON PLUGGED SER. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-09 | 14 | 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