Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GKJ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
87 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854962 | MICRO-MAT SYSTEM | Ulster Scientific, Inc. | 1985-12-23 | 12 | 0 |
| K854121 | MICRO-MAT SYSTEM | Prevo Micro-Mat System | 1985-10-31 | 22 | 0 |
| K831558 | E-Z PREP | Coulter Electronics, Inc. | 1983-06-16 | 31 | 0 |
| K811534 | HEMASPINNER | Geometric Data, Div. Smithkline Corp. | 1981-08-18 | 78 | 0 |
| K771898 | AUTOMATED SLIDE SPINNER | Dynatech Cryomedical Co. | 1977-10-18 | 12 | 0 |
| K760007 | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | Geometric Data, Div. Smithkline Corp. | 1976-09-03 | 87 | 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