FDA product code KRA: Catheter, Continuous Flush
KRA is the FDA product code for catheter, continuous flush. It is a Class II device, regulated under 21 CFR 870.1210 and reviewed by the Cardiovascular panel. FDA has cleared 176 510(k) submissions under KRA, 18 in the last five years, from 83 different applicants. The average 510(k) review took 122 days (median 84); 220 days on average over the last three years. FDA has posted 96 recalls for KRA devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Continuous Flush |
| Device class | Class II |
| Regulation | 21 CFR 870.1210 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KRA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 146 |
| 2018 | 4 | 189 |
| 2019 | 4 | 139 |
| 2020 | 6 | 83 |
| 2021 | 6 | 102 |
| 2022 | 6 | 194 |
| 2023 | 7 | 103 |
| 2025 | 1 | 257 |
| 2026 | 4 | 182 |
Compare with all 510(k) review times · Search every KRA clearance
Top KRA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro Therapeutics, Inc. | 17 | 2012-08-01 |
| Cordis Neurovascular, Inc. | 13 | 2007-03-14 |
| Cook, Inc. | 8 | 2014-02-20 |
| Merit Medical Systems, Inc. | 7 | 2021-07-16 |
| Boston Scientific Corp | 7 | 2014-09-10 |
78 more applicants have KRA clearances. See the full list in Caduvo.
Most recent KRA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254051 | SmartWise Sweden AB | Extroducer Infusion Catheter System | 2026-09-11 | 268 |
| K261610 | Instylla, Inc. | Verge Microcatheter | 2026-06-11 | 28 |
| K260771 | Boston Scientific Corporation | TruSelect 2.6 Microcatheter | 2026-05-15 | 67 |
| K250794 | Invera Medical | InVera Infusion Device | 2026-03-12 | 363 |
| K243534 | Suzhou Zenith Vascular SciTech Limited | Micro Catheter | 2025-07-30 | 257 |
Recalls for KRA devices
96 product recalls in 49 recall events; 4 initiated in the last five years and 5 still open. Most recent: 2023-12-18.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 4 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code KRA?
KRA is the FDA product code for catheter, continuous flush. It is a Class II device, regulated under 21 CFR 870.1210 and reviewed by the Cardiovascular panel.
What device class is KRA?
Class II, regulation 21 CFR 870.1210. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRA?
Across 176 cleared submissions the average was 122 days from receipt to decision (median 84).
Which companies have the most KRA clearances?
Micro Therapeutics, Inc. (17); Cordis Neurovascular, Inc. (13); Cook, Inc. (8); Merit Medical Systems, Inc. (7); Boston Scientific Corp (7).
Have KRA devices been recalled?
Yes: 96 product recalls across 49 recall events; the most recent began 2023-12-18.
Next steps
- Run an FDA pathway report with predicate devices for product code KRA
- Run a recall and safety report across every KRA manufacturer
- Watch product code KRA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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