FDA product code · Cardiovascular · Class 2
KRD: Device, Vascular, For Promoting Embolization
KRD is FDA's product code for "Device, Vascular, For Promoting Embolization": a Class 2 device classified under 21 CFR 870.3300, reviewed by the Cardiovascular panel. FDA flags it as an implant.
510(k) review time for KRD
Across 48 510(k) clearances under KRD decided from 2018-01-01 to 2026-10-06, the median was 104 days from FDA receipt to decision. Half took between 51 and 182 days, and 80% were decided within 231 days. These are past clearances, not a forecast for a new submission.
| Fastest | 20 |
|---|---|
| 25th percentile | 51 |
| Median | 104 |
| 75th percentile | 182 |
| 80th percentile | 231 |
| 90th percentile | 261 |
| Slowest | 330 |
| Year | Median days | n |
|---|---|---|
| 2019 | 178 | 6 |
| 2022 | 175 | 8 |
| 2024 | 70 | 6 |
| 2025 | 60 | 9 |
| 2026 (to 10-06, partial) | 75 | 6 |
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.
KRD in the public FDA record
| 510(k) clearances, all years | 132 |
|---|---|
| Device recalls | 19 |
| Establishment listings | 508 |
| GUDID device identifiers | 6,709 |
Counts of records, not of devices or events. Adverse event reports for KRD 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 KRD
No FDA recognized consensus standard cites KRD 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.