Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roche Diagnostics Corporation — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
243 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141929 | ACCU-CHEK CONNECT DIABETES MANAGEMENT APP | Roche Diagnostics Corporation | 2015-03-16 | 243 | 1 |
| K142089 | ACCU-CHEK AVIVA EXPERT SYSTEM | Roche Diagnostics Corporation | 2014-12-17 | 138 | 0 |
| K133862 | ACCU-CHEK AVIVA PLUS SYSTEM | Roche Diagnostics Corporation | 2014-04-29 | 131 | 2 |
| K112528 | ELECSYS T4 CALCHECK 5 | Roche Diagnostics Corporation | 2011-10-18 | 48 | 0 |
| K070172 | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Diagnostics Corporation | 2007-04-17 | 89 | 0 |
| K070174 | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS | Roche Diagnostics Corporation | 2007-04-16 | 88 | 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