Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Challenge Mfg., 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) |
|---|---|---|---|---|---|
| K910788 | CMI TENDER TOUCH VE #303TT AND 404TT | Challenge Mfg., Inc. | 1991-05-09 | 73 | 0 |
| K895446 | CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) | Challenge Mfg., Inc. | 1989-11-27 | 80 | 0 |
| K881306 | CMI VACUUM DELIVERY SYSTEM #003C AND #004C | Challenge Mfg., Inc. | 1988-06-13 | 77 | 0 |
| K881967 | CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) | Challenge Mfg., Inc. | 1988-06-13 | 33 | 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