Cleared Traditional

CARDIODRIVE, MODEL 001-004115 (NON-STERILE) (K042850) - FDA 510(k) Clearance

Also marketed or referenced as:
001-1169-1 (STERILE)

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

K042850 · Stereotaxis, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
663d
Days
Class 2
Risk

K042850 is an FDA 510(k) clearance for the CARDIODRIVE, MODEL 001-004115 (NON-STERILE). Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on August 9, 2006 after a review of 663 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Stereotaxis, Inc. devices

Submission Details

510(k) Number K042850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2004
Decision Date August 09, 2006
Days to Decision 663 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
538d slower than avg
Panel avg: 125d · This submission: 663d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 888
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