KRD · Class II · 21 CFR 870.3300

FDA Product Code KRD: Device, Vascular, For Promoting Embolization

Under FDA product code KRD, vascular embolization devices are cleared for the occlusion of blood vessels in therapeutic endovascular procedures.

These devices — including coils, plugs, and liquid embolic agents — are delivered through catheters to deliberately occlude target vessels, reducing blood flow to tumors, aneurysms, or arteriovenous malformations. Embolization is a cornerstone of interventional radiology and neurovascular surgery.

KRD devices are Class II medical devices, regulated under 21 CFR 870.3300 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Boston Scientific Corp, Boston Scientific Corporation and Biosphere Medical, S.A..

128
Total
128
Cleared
121d
Avg days
1985
Since
Growing category - 14 submissions in the last 2 years vs 8 in the prior period
Review times improving: avg 93d recently vs 124d historically

FDA 510(k) Cleared Device, Vascular, For Promoting Embolization Devices (Product Code KRD)

128 devices
1–24 of 128
Cleared Apr 10, 2026
LOBO Vascular Occlusion System
K260508
Okami Medical, Inc.
Cardiovascular · 52d
Cleared Jan 14, 2026
Concerto Versa™ Detachable Coil
K253511
Medtronic, Inc.
Cardiovascular · 70d
Cleared Dec 15, 2025
Tembo Embolic System
K253677
Instylla, Inc.
Cardiovascular · 24d
Cleared Oct 30, 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
K253376
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 23, 2025
Polyvinyl Alcohol Embolic Microspheres
K250209
Canyon Medical, Inc.
Obstetrics & Gynecology · 242d
Cleared Jul 09, 2025
HARBOR Occlusion Device
K250133
Nuvascular, Inc.
Cardiovascular · 173d
Cleared May 30, 2025
Prestige Coil System (Prestige Packing Line Extension)
K251383
Balt USA, LLC
Cardiovascular · 28d
Cleared May 16, 2025
Embosphere Microspheres
K250971
Biosphere Medical, S.A.
Cardiovascular · 46d
Cleared May 15, 2025
Nitinol Enhanced Device (NED)
K250276
Embolization, Inc.
Cardiovascular · 104d
Cleared Mar 14, 2025
Ruby XL System
K250079
Penumbra, Inc.
Cardiovascular · 60d
Cleared Jan 17, 2025
Embozene Color-Advanced Microspheres
K242608
Varian Medical Systems, Inc.
Gastroenterology & Urology · 136d
Cleared Dec 16, 2024
TEMBO Embolic System
K240873
Instylla, Inc.
Cardiovascular · 262d
Cleared Oct 16, 2024
ONCOZENE Microspheres
K242794
Varian Medical Systems, Inc.
Cardiovascular · 30d
Cleared Oct 03, 2024
OBSIDIO™ Conformable Embolic
K242507
Boston Scientific
Cardiovascular · 42d
Cleared May 30, 2024
Sunsphere
K232934
Hangzhou Yangshun Medical Technology Co.,Ltd
Obstetrics & Gynecology · 253d
Cleared May 02, 2024
Siege Vascular Plug (SVP2.5-0.021)
K240261
Merit Medical Systems, Inc.
Cardiovascular · 92d
Cleared Feb 13, 2024
Easi-Vue® embolic microspheres System
K234123
Abk Biomedical, Inc.
Cardiovascular · 47d
Cleared Nov 14, 2023
UniPearls® Embolic Microspheres
K231554
Suzhou Haowei Medical Technology Co., Ltd.
Gastroenterology & Urology · 168d
Cleared Jun 27, 2023
EMBOLD™ Soft Detachable Coil System
K230706
Boston Scientific Corporation
Cardiovascular · 105d
Cleared Dec 21, 2022
AZUR HydroPack 18 (45-880005
K223050
MicroVention, Inc.
Cardiovascular · 83d
Cleared Sep 07, 2022
Easi-Vue embolic microspheres System
K220567
Abk Biomedical, Inc.
Cardiovascular · 191d
Cleared Jul 01, 2022
GEM
K213385
Obsidio, Inc.
Cardiovascular · 261d
Cleared Apr 29, 2022
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
K220383
Okami Medical
Cardiovascular · 78d
Cleared Apr 12, 2022
EMBOLD Fibered Detachable Coil System
K213398
Boston Scientific Corporation
Cardiovascular · 176d

About Product Code KRD - Regulatory Context

510(k) Submission Activity

128 total 510(k) submissions under product code KRD since 1985, with 128 receiving FDA clearance (average review time: 121 days).

Submission volume has increased in recent years - 14 submissions in the last 24 months compared to 8 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KRD Product Code

Recent submissions under KRD have taken an average of 93 days to reach a decision - down from 124 days historically, suggesting improved FDA processing for this classification.

KRD devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →