FDA product code · Neurology · Class 2
HAE: Rongeur, Manual
HAE is FDA's product code for "Rongeur, Manual": a Class 2 device classified under 21 CFR 882.4840, reviewed by the Neurology panel.
510(k) review time for HAE
Across 10 510(k) clearances under HAE decided from 2018-01-01 to 2026-10-06, the median was 210 days from FDA receipt to decision. Half took between 154 and 254 days, and 80% were decided within 295 days. These are past clearances, not a forecast for a new submission.
| Fastest | 31 |
|---|---|
| 25th percentile | 154 |
| Median | 210 |
| 75th percentile | 254 |
| 80th percentile | 295 |
| 90th percentile | 409 |
| Slowest | 448 |
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.
HAE in the public FDA record
| 510(k) clearances, all years | 36 |
|---|---|
| Establishment listings | 95 |
| GUDID device identifiers | 10,437 |
Counts of records, not of devices or events. Adverse event reports for HAE 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 HAE
No FDA recognized consensus standard cites HAE 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.