FDA product code · Clinical Chemistry · Class 2
QFG: Alternate Controller Enabled Insulin Infusion Pump
QFG is FDA's product code for "Alternate Controller Enabled Insulin Infusion Pump": a Class 2 device classified under 21 CFR 880.5730, reviewed by the Clinical Chemistry panel.
510(k) review time for QFG
Across 28 510(k) clearances under QFG decided from 2018-01-01 to 2026-10-06, the median was 98 days from FDA receipt to decision. Half took between 41 and 253 days, and 80% were decided within 261 days. These are past clearances, not a forecast for a new submission.
| Fastest | 5 |
|---|---|
| 25th percentile | 41 |
| Median | 98 |
| 75th percentile | 253 |
| 80th percentile | 261 |
| 90th percentile | 421 |
| Slowest | 682 |
| Year | Median days | n |
|---|---|---|
| 2023 | 150 | 9 |
| 2024 | 89 | 5 |
| 2025 | 44 | 5 |
| 2026 (to 10-06, partial) | 108 | 5 |
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.
QFG in the public FDA record
| Device recalls | 21 |
|---|
Counts of records, not of devices or events. Adverse event reports for QFG are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite QFG
No FDA recognized consensus standard cites QFG 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.