Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Haemoscope Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
186 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062604 | RAPIDTEG TEG-ACT TEST | Haemoscope Corp. | 2007-01-31 | 152 | 0 |
| K041502 | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | Haemoscope Corp. | 2004-09-01 | 86 | 0 |
| K002177 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES | Haemoscope Corp. | 2000-09-14 | 57 | 4 |
| K993678 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES | Haemoscope Corp. | 2000-05-05 | 186 | 0 |
| K954437 | THROMBELASTOGRAPH COAGULATION ANALYZER 3000S | Haemoscope Corp. | 1996-01-30 | 130 | 0 |
| K904204 | THROMBELASTOGRAPH | Haemoscope Corp. | 1990-11-01 | 50 | 0 |
| K895844 | THROMBELASTOGRAPH(R) | Haemoscope Corp. | 1989-10-24 | 21 | 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