Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dimension Diagnostics — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
201 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863223 | DIMENSION-WBG | Dimension Diagnostics | 1987-03-10 | 201 | 0 |
| K861366 | ALT-30, 60 AND 100 | Dimension Diagnostics | 1986-06-25 | 75 | 0 |
| K854967 | CRITIC - SF, ASSAYED | Dimension Diagnostics | 1986-01-07 | 27 | 0 |
| K853943 | CRITIC C LEVEL I & II | Dimension Diagnostics | 1985-12-23 | 90 | 0 |
| K852295 | UROL-GUANT | Dimension Diagnostics | 1985-07-22 | 54 | 0 |
| K844848 | IMA-TROL IMMUNOASSAY CONTROL | Dimension Diagnostics | 1985-03-01 | 78 | 0 |
| K844760 | UROL-QUAL | Dimension Diagnostics | 1985-01-08 | 32 | 0 |
| K844709 | CRITIC-ARS | Dimension Diagnostics | 1985-01-08 | 36 | 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