FDA product code · Gastroenterology, Urology · Class 2
KDN: System, Perfusion, Kidney
KDN is FDA's product code for "System, Perfusion, Kidney": a Class 2 device classified under 21 CFR 876.5880, reviewed by the Gastroenterology, Urology panel.
510(k) review time for KDN
Across 22 510(k) clearances under KDN decided from 2018-01-01 to 2026-10-06, the median was 168 days from FDA receipt to decision. Half took between 113 and 240 days, and 80% were decided within 258 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 113 |
| Median | 168 |
| 75th percentile | 240 |
| 80th percentile | 258 |
| 90th percentile | 302 |
| Slowest | 459 |
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.
KDN in the public FDA record
| 510(k) clearances, all years | 44 |
|---|
Counts of records, not of devices or events. Adverse event reports for KDN 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 KDN
No FDA recognized consensus standard cites KDN 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.
Related product codes
- FGB Ureteroscope And Accessories, Flexible/Rigid
- KNT Tubes, Gastrointestinal (And Accessories)
- KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
- KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- FGE Stents, Drains And Dilators For The Biliary Ducts
- PKL Hemostatic Metal Clip For The Gi Tract