Cleared Special

LOBO Vascular Occlusion System (model LOBO-5) (K203025) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K203025 · Okami Medical · Cardiovascular device
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Nov 2020
Decision
34d
Days
Class 2
Risk

K203025 is an FDA 510(k) clearance for the LOBO Vascular Occlusion System (model LOBO-5). Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Okami Medical (Aliso Viejo, US). The FDA issued a Cleared decision on November 5, 2020 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Okami Medical devices

Submission Details

510(k) Number K203025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2020
Decision Date November 05, 2020
Days to Decision 34 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 70
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K203025.
Merit Siege Vascular Plug
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HRSpheres Narrow-Size Embolic Microspheres
K210562 · Suzhou Hengrui Hongyuan Medical Co., Ltd. · Oct 2021
Concerto Versa, Detachable Coil
K202850 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Feb 2021
AZUR Vascular Plug
K191680 · MicroVention, Inc. · Mar 2020
EMBA Hourglass Peripheral Embolization Device (PED)
K200083 · Embolic Acceleration, LLC · Feb 2020
The Caterpillar and Caterpillar Micro Arterial Embolization Devices
K191532 · C.R. Bard, Inc. · Feb 2020