FDA product code · Cardiovascular · Class 2
PNO: Catheter, Percutaneous, Cutting/Scoring
PNO is FDA's product code for "Catheter, Percutaneous, Cutting/Scoring": a Class 2 device classified under 21 CFR 870.1250, reviewed by the Cardiovascular panel.
510(k) review time for PNO
Across 16 510(k) clearances under PNO decided from 2018-01-01 to 2026-10-06, the median was 136 days from FDA receipt to decision. Half took between 51 and 233 days, and 80% were decided within 257 days. These are past clearances, not a forecast for a new submission.
| Fastest | 19 |
|---|---|
| 25th percentile | 51 |
| Median | 136 |
| 75th percentile | 233 |
| 80th percentile | 257 |
| 90th percentile | 265 |
| Slowest | 322 |
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.
PNO in the public FDA record
| 510(k) clearances, all years | 45 |
|---|---|
| GUDID device identifiers | 813 |
Counts of records, not of devices or events. Adverse event reports for PNO 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 PNO
1 FDA recognized consensus standard cite PNO, 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.