Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Imation Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
88 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984252 | IMATION TRIMATIC DIGITAL SYSTEM | Imation Corp. | 1999-01-25 | 59 | 0 |
| K980722 | TRIMAX RADIOGRAPHIC CASSETTE | Imation Corp. | 1998-03-23 | 27 | 0 |
| K973303 | IMATION MODEL 9410 NETWORK INTERFACE | Imation Corp. | 1997-11-25 | 83 | 0 |
| K972163 | IMATION SE-196 LASER IMAGER | Imation Corp. | 1997-09-05 | 88 | 0 |
| K962750 | 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AU | Imation Corp. | 1996-08-21 | 37 | 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