FDA product code · Immunology · Class 2
NXO: Calprotectin, Fecal
NXO is FDA's product code for "Calprotectin, Fecal": a Class 2 device classified under 21 CFR 866.5180, reviewed by the Immunology panel.
510(k) review time for NXO
Across 11 510(k) clearances under NXO decided from 2018-01-01 to 2026-10-06, the median was 90 days from FDA receipt to decision. Half took between 69 and 198 days, and 80% were decided within 210 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 69 |
| Median | 90 |
| 75th percentile | 198 |
| 80th percentile | 210 |
| 90th percentile | 228 |
| Slowest | 393 |
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 NXO
No FDA recognized consensus standard cites NXO 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.