Cleared Traditional

K992121 - EMBOLIZATION COIL SYSTEM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992121 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
180d
Days
Class 2
Risk

K992121 is an FDA 510(k) clearance for the EMBOLIZATION COIL SYSTEM. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 180 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 Cook, Inc. devices

Submission Details

510(k) Number K992121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1999
Decision Date December 20, 1999
Days to Decision 180 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 127
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K992121.
LOBO Vascular Occlusion System
K260508 · Okami Medical, Inc. · Apr 2026
Concerto Versa™ Detachable Coil
K253511 · Medtronic, Inc. · Jan 2026
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
HARBOR Occlusion Device
K250133 · Nuvascular, Inc. · Jul 2025