Cleared Traditional

K262798 - LOBO Vascular Occlusion System

K262798 is an FDA 510(k) clearance for LOBO Vascular Occlusion System, manufactured by Okami Medical, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K262798 · Okami Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
60d
Days
Class 2
Risk

K262798 is an FDA 510(k) clearance for the LOBO Vascular Occlusion System. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Okami Medical, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on October 6, 2026 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262798

510(k) Number K262798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2026
Decision Date October 06, 2026
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K262798.
UniPearls® Embolic Microspheres
K252812 · Suzhou Haowei Medical Technology Co., Ltd. · Jul 2026
OBSIDIO Conformable Embolic
K261488 · Boston Scientific Corporation · Jul 2026
Concerto Versa™ Detachable Coil
K261866 · Medtronic, Inc. · Jun 2026
HARBOR Occlusion Device
K260635 · Nuvascular, Inc. · Jun 2026
LOBO Vascular Occlusion System
K260508 · Okami Medical, Inc. · Apr 2026
Concerto Versa™ Detachable Coil
K253511 · Medtronic, Inc. · Jan 2026
K262798 · LOBO Vascular Occlusion System
Download PDF FDA Summary Okami Medical, Inc.