Cleared Traditional

STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM (K021555) - FDA 510(k) Clearance

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

K021555 · Stereotaxis, Inc. · Cardiovascular device
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Jan 2003
Decision
247d
Days
Class 2
Risk

K021555 is an FDA 510(k) clearance for the STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on January 15, 2003 after a review of 247 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - 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 Stereotaxis, Inc. devices

Submission Details

510(k) Number K021555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2002
Decision Date January 15, 2003
Days to Decision 247 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
122d slower than avg
Panel avg: 125d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
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 - DXX System, Catheter Control, Steerable

All 32
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K021555.
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