Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hemocleanse, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
828 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993330 | THERMOCHEM-HT SYSTEM | Hemocleanse, Inc. | 1999-12-30 | 87 | 0 |
| K992196 | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) | Hemocleanse, Inc. | 1999-09-10 | 72 | 0 |
| K984546 | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT | Hemocleanse, Inc. | 1999-08-13 | 234 | 0 |
| K953751 | BIOLOGIC-DT SYSTEM | Hemocleanse, Inc. | 1996-02-15 | 189 | 0 |
| K923046 | BIOLOGIC DT-1000 MACHINE | Hemocleanse, Inc. | 1994-09-30 | 828 | 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