FDA product code KRD: Device, Vascular, For Promoting Embolization
KRD is the FDA product code for device, vascular, for promoting embolization. It is a Class II device, regulated under 21 CFR 870.3300 and reviewed by the Cardiovascular panel. FDA has cleared 132 510(k) submissions under KRD, 31 in the last five years, from 53 different applicants. The average 510(k) review took 121 days (median 90); 108 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 20 recalls for KRD devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Vascular, For Promoting Embolization |
| Device class | Class II |
| Regulation | 21 CFR 870.3300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KRD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 96 |
| 2018 | 4 | 79 |
| 2019 | 6 | 174 |
| 2020 | 4 | 143 |
| 2021 | 3 | 152 |
| 2022 | 8 | 154 |
| 2023 | 2 | 136 |
| 2024 | 6 | 121 |
| 2025 | 9 | 94 |
| 2026 | 6 | 110 |
Compare with all 510(k) review times · Search every KRD clearance
Top KRD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| MicroVention, Inc. | 18 | 2022-12-21 |
| Biosphere Medical, S.A. | 9 | 2025-05-16 |
| Boston Scientific Corporation | 7 | 2026-07-24 |
| Boston Scientific Corp | 7 | 2013-11-14 |
| Cook, Inc. | 7 | 2009-04-02 |
48 more applicants have KRD clearances. See the full list in Caduvo.
Most recent KRD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252812 | Suzhou Haowei Medical Technology Co., Ltd. | UniPearls® Embolic Microspheres | 2026-07-31 | 330 |
| K261488 | Boston Scientific Corporation | OBSIDIO Conformable Embolic | 2026-07-24 | 79 |
| K261866 | Medtronic, Inc. | Concerto Versa Detachable Coil | 2026-06-24 | 20 |
| K260635 | Nuvascular, Inc. | HARBOR Occlusion Device | 2026-06-12 | 106 |
| K260508 | Okami Medical, Inc. | LOBO Vascular Occlusion System | 2026-04-10 | 52 |
Recalls for KRD devices
20 product recalls in 13 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2026-08-10.
| Year | Recalls |
|---|---|
| 2019 | 6 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KRD?
KRD is the FDA product code for device, vascular, for promoting embolization. It is a Class II device, regulated under 21 CFR 870.3300 and reviewed by the Cardiovascular panel.
What device class is KRD?
Class II, regulation 21 CFR 870.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRD?
Across 132 cleared submissions the average was 121 days from receipt to decision (median 90).
Which companies have the most KRD clearances?
MicroVention, Inc. (18); Biosphere Medical, S.A. (9); Boston Scientific Corporation (7); Boston Scientific Corp (7); Cook, Inc. (7).
Have KRD devices been recalled?
Yes: 20 product recalls across 13 recall events; the most recent began 2026-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code KRD
- Run a recall and safety report across every KRD manufacturer
- Watch product code KRD 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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