Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GKM · 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) |
|---|---|---|---|---|---|
| K874188 | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA | Coulter Electronics, Inc. | 1988-01-19 | 97 | 0 |
| K854685 | DIGITAL-9 KEY LEUCOCYTE COUNTER | Future Impex Corp. | 1986-04-04 | 135 | 0 |
| K841026 | MANUAL BLOOD CELL COUNTING DEVICE | Instrumentation Laboratory CO | 1984-04-04 | 23 | 0 |
| K771580 | TEKTALLY II | Scientific Products | 1977-09-02 | 15 | 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