Cleared Traditional

COBE HEMODYNAMIC RECIRCULATION MONITOR (K954003) - FDA 510(k) Clearance

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

K954003 · Cobe Renal Care, Inc. · Gastroenterology & Urology device
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Feb 1997
Decision
531d
Days
Class 2
Risk

K954003 is an FDA 510(k) clearance for the COBE HEMODYNAMIC RECIRCULATION MONITOR. Classified as System, Hemodialysis, Access Recirculation Monitoring (product code MQS), Class II - Special Controls.

Submitted by Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on February 6, 1997 after a review of 531 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology submissions.

View all Cobe Renal Care, Inc. devices

Submission Details

510(k) Number K954003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date February 06, 1997
Days to Decision 531 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
401d slower than avg
Panel avg: 130d · This submission: 531d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQS System, Hemodialysis, Access Recirculation Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.