Cleared Traditional

K951739 - PUMP/BLOOD CHEMISTRY MONITOR (FDA 510(k) Clearance)

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

K951739 · Via Medical Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1996
Decision
320d
Days
Class 2
Risk

K951739 is an FDA 510(k) clearance for the PUMP/BLOOD CHEMISTRY MONITOR. Classified as Pump, Infusion, Analytical Sampling (product code LZF), Class II - Special Controls.

Submitted by Via Medical Corp. (San Diego, US). The FDA issued a Cleared decision on February 28, 1996 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Via Medical Corp. devices

Submission Details

510(k) Number K951739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1995
Decision Date February 28, 1996
Days to Decision 320 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 128d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZF Pump, Infusion, Analytical Sampling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.