Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hematronix, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
368 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012243 | MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL | Hematronix, Inc. | 2001-08-20 | 34 | 0 |
| K993496 | RETIC-QUINOX | Hematronix, Inc. | 1999-11-30 | 46 | 0 |
| K972710 | QUANTIFY(901) | Hematronix, Inc. | 1997-08-15 | 25 | 0 |
| K960471 | TRI-COUNT 20 | Hematronix, Inc. | 1996-03-20 | 48 | 0 |
| K960005 | TRI-COURT 20-T | Hematronix, Inc. | 1996-03-19 | 77 | 0 |
| K941965 | EZ-RANGE | Hematronix, Inc. | 1995-04-25 | 368 | 0 |
| K935343 | CENTRIFIQ BLOOD CONTROL | Hematronix, Inc. | 1994-01-27 | 128 | 0 |
| K904461 | METER TRAX | Hematronix, Inc. | 1990-10-26 | 25 | 0 |
| K902389 | TRI-COUNT 16 | Hematronix, Inc. | 1990-08-22 | 84 | 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