10xAnd
Scoping review

FDA product code · Gastroenterology, Urology · Class 2

FAD: Stent, Ureteral

FAD is FDA's product code for "Stent, Ureteral": a Class 2 device classified under 21 CFR 876.4620, reviewed by the Gastroenterology, Urology panel. FDA flags it as an implant.

510(k) review time for FAD

Across 28 510(k) clearances under FAD decided from 2018-01-01 to 2026-10-06, the median was 247 days from FDA receipt to decision. Half took between 142 and 266 days, and 80% were decided within 268 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, FAD, decisions 2018-01-01 to 2026-10-06 (n = 28)
Fastest28
25th percentile142
Median247
75th percentile266
80th percentile268
90th percentile289
Slowest506
Median days by decision year, FAD (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20182589
20192635
20221435

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.

FAD in the public FDA record

Records naming FAD, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years122
Device recalls55
Establishment listings231
GUDID device identifiers3,837

Counts of records, not of devices or events. Adverse event reports for FAD 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 FAD

1 FDA recognized consensus standard cite FAD, among them ASTM F1828-22. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 9-151 ASTM F1828-22 — Standard Specification for Ureteral Stents

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

Related product codes