Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oec-Diasonics, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
100 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926056 | 9600 FLUOROSCOPIC IMAGING SYSTEM | Oec-Diasonics, Inc. | 1993-01-21 | 51 | 0 |
| K924879 | EP 3000 | Oec-Diasonics, Inc. | 1993-01-04 | 98 | 0 |
| K914446 | UROVIEW 2000, MODIFICATION | Oec-Diasonics, Inc. | 1992-01-10 | 98 | 2 |
| K896583 | F.A.S.T. TABLE | Oec-Diasonics, Inc. | 1990-03-01 | 100 | 0 |
| K893475 | UROVIEW II | Oec-Diasonics, Inc. | 1989-08-10 | 98 | 1 |
| K872022 | UROVIEW | Oec-Diasonics, Inc. | 1987-07-16 | 51 | 0 |
| K864837 | MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM | Oec-Diasonics, Inc. | 1987-01-30 | 52 | 0 |
| K843972 | ANGIOPLUS-S | Oec-Diasonics, Inc. | 1985-01-03 | 84 | 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