Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QRX — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
400 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025-11-18 | 75 | 0 |
| K231824 | SmartBolus Calculator | Insulet Corporation | 2023-10-18 | 119 | 0 |
| K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023-08-11 | 322 | 0 |
| K222239 | SmartBolus Calculator | Insulet Corporation | 2022-08-19 | 24 | 0 |
| K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022-01-27 | 400 | 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