Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roche Diabetes Care, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
501 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | 2023-11-13 | 88 | 0 |
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | 2023-11-13 | 87 | 0 |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | 2022-05-19 | 57 | 0 |
| K203711 | IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2022-05-06 | 501 | 0 |
| K220608 | Accu-Chek FastClix Blood Lancing System | Roche Diabetes Care, Inc. | 2022-04-29 | 58 | 0 |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | 2022-04-05 | 56 | 0 |
| K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | 2022-02-17 | 57 | 0 |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2016-08-31 | 148 | 2 |
| K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015-06-03 | 61 | 2 |
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