FDA product code · Cardiovascular · Class 2
NLH: Catheter, Recording, Electrode, Reprocessed
NLH is FDA's product code for "Catheter, Recording, Electrode, Reprocessed": a Class 2 device classified under 21 CFR 870.1220, reviewed by the Cardiovascular panel.
510(k) review time for NLH
Across 22 510(k) clearances under NLH decided from 2018-01-01 to 2026-10-06, the median was 141 days from FDA receipt to decision. Half took between 119 and 187 days, and 80% were decided within 195 days. These are past clearances, not a forecast for a new submission.
| Fastest | 40 |
|---|---|
| 25th percentile | 119 |
| Median | 141 |
| 75th percentile | 187 |
| 80th percentile | 195 |
| 90th percentile | 206 |
| Slowest | 414 |
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.
NLH in the public FDA record
| 510(k) clearances, all years | 70 |
|---|---|
| Device recalls | 48 |
| Establishment listings | 153 |
| GUDID device identifiers | 2,140 |
Counts of records, not of devices or events. Adverse event reports for NLH 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 NLH
1 FDA recognized consensus standard cite NLH, among them AAMI TIR42:2021. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-172 AAMI TIR42:2021 — Evaluation of Particulates Associated with Vascular Medical Devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.