Cleared Traditional

K250133 - HARBOR Occlusion Device

K250133 is an FDA 510(k) clearance for HARBOR Occlusion Device, manufactured by Nuvascular, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K250133 · Nuvascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
173d
Days
Class 2
Risk

K250133 is an FDA 510(k) clearance for the HARBOR Occlusion Device. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Nuvascular, Inc. (Irvine, US). The FDA issued a Cleared decision on July 9, 2025 after a review of 173 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuvascular, Inc. devices

FDA 510(k) Submission Details - K250133

510(k) Number K250133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2025
Decision Date July 09, 2025
Days to Decision 173 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
48d slower than avg
Panel avg: 125d · This submission: 173d
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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K250133.
Tembo Embolic System
K253677 · Instylla, Inc. · Dec 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
K253376 · Boston Scientific Corporation · Oct 2025
Polyvinyl Alcohol Embolic Microspheres
K250209 · Canyon Medical, Inc. · Sep 2025
Prestige Coil System (Prestige Packing Line Extension)
K251383 · Balt USA, LLC · May 2025
Embosphere Microspheres
K250971 · Biosphere Medical, S.A. · May 2025
Nitinol Enhanced Device (NED)
K250276 · Embolization, Inc. · May 2025