FDA product code · Cardiovascular · Class 2
KRA: Catheter, Continuous Flush
KRA is FDA's product code for "Catheter, Continuous Flush": a Class 2 device classified under 21 CFR 870.1210, reviewed by the Cardiovascular panel.
510(k) review time for KRA
Across 39 510(k) clearances under KRA decided from 2018-01-01 to 2026-10-06, the median was 136 days from FDA receipt to decision. Half took between 38 and 228 days, and 80% were decided within 261 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 38 |
| Median | 136 |
| 75th percentile | 228 |
| 80th percentile | 261 |
| 90th percentile | 268 |
| Slowest | 363 |
| Year | Median days | n |
|---|---|---|
| 2020 | 29 | 6 |
| 2021 | 108 | 6 |
| 2022 | 228 | 6 |
| 2023 | 63 | 7 |
| 2026 (to 10-06, partial) | 268 | 5 |
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.
KRA in the public FDA record
| 510(k) clearances, all years | 175 |
|---|---|
| Device recalls | 96 |
| Establishment listings | 619 |
| GUDID device identifiers | 1,842 |
Counts of records, not of devices or events. Adverse event reports for KRA 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 KRA
1 FDA recognized consensus standard cite KRA, 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.