Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JRC · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
100 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840186 | SMI DIGITRON | Scientific Manufacturing Industries | 1984-04-05 | 78 | 0 |
| K834100 | PRE-CALIBRATED PIPETTES | Vitex | 1984-02-21 | 83 | 0 |
| K822078 | DADE DISP. DISPENSING-SPREADING PIPETS | American Dade | 1982-07-27 | 12 | 0 |
| K792696 | MICROPITETTE | Meridian Diagnostics, Inc. | 1980-02-01 | 36 | 0 |
| K770594 | LABORATORY EXPENDABLE PRODUCTS | Abco Dealers, Inc. | 1977-07-06 | 100 | 0 |
| K760621 | LANCER PLASTIC TRANSFER PIPETTE | Sherwood Medical Industries | 1976-10-05 | 22 | 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