Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Care Wise Medical Products Corp. · 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) |
|---|---|---|---|---|---|
| K982442 | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO | Care Wise Medical Products Corp. | 1998-08-25 | 42 | 0 |
| K922117 | C-TRAK BIOPSY SYSTEM | Care Wise Medical Products Corp. | 1992-10-14 | 162 | 0 |
| K896588 | ONCOPROBE II SYSTEM | Care Wise Medical Products Corp. | 1990-03-14 | 113 | 0 |
| K884770 | ONCOPROBE SYSTEM | Care Wise Medical Products Corp. | 1989-01-04 | 51 | 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