FDA product code · Clinical Chemistry · Class 2
QJI: Interoperable Automated Glycemic Controller
QJI is FDA's product code for "Interoperable Automated Glycemic Controller": a Class 2 device classified under 21 CFR 862.1356, reviewed by the Clinical Chemistry panel.
510(k) review time for QJI
Across 23 510(k) clearances under QJI decided from 2018-01-01 to 2026-10-06, the median was 87 days from FDA receipt to decision. Half took between 68 and 219 days, and 80% were decided within 259 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 68 |
| Median | 87 |
| 75th percentile | 219 |
| 80th percentile | 259 |
| 90th percentile | 374 |
| Slowest | 767 |
| Year | Median days | n |
|---|---|---|
| 2025 | 130 | 5 |
| 2026 (to 10-06, partial) | 58 | 7 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite QJI
No FDA recognized consensus standard cites QJI by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.