FDA product code · Clinical Toxicology · Class 2
NGL: Test, Opiates, Over The Counter
NGL is FDA's product code for "Test, Opiates, Over The Counter": a Class 2 device classified under 21 CFR 862.3650, reviewed by the Clinical Toxicology panel.
510(k) review time for NGL
Across 21 510(k) clearances under NGL decided from 2018-01-01 to 2026-10-06, the median was 36 days from FDA receipt to decision. Half took between 30 and 52 days, and 80% were decided within 54 days. These are past clearances, not a forecast for a new submission.
| Fastest | 16 |
|---|---|
| 25th percentile | 30 |
| Median | 36 |
| 75th percentile | 52 |
| 80th percentile | 54 |
| 90th percentile | 93 |
| Slowest | 175 |
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.
NGL in the public FDA record
| Establishment listings | 190 |
|---|---|
| GUDID device identifiers | 2,165 |
Counts of records, not of devices or events. Adverse event reports for NGL 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 NGL
No FDA recognized consensus standard cites NGL 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.