Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oncology Data Systems, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102583 | MUCHECK, VERSION 9.0 | Oncology Data Systems, Inc. | 2010-11-02 | 55 | 0 |
| K091602 | MUCHECK V8 | Oncology Data Systems, Inc. | 2009-06-18 | 15 | 0 |
| K061152 | MUCHECK V7.0 | Oncology Data Systems, Inc. | 2006-05-10 | 14 | 0 |
| K012227 | MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 | Oncology Data Systems, Inc. | 2001-10-01 | 77 | 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