Cleared Traditional

K922997 - VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. (FDA 510(k) Clearance)

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

K922997 · Via Medical Corp. · General Hospital
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Jan 1994
Decision
568d
Days
Class 2
Risk

K922997 is an FDA 510(k) clearance for the VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.. 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 January 11, 1994 after a review of 568 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: 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 General Hospital submissions.

View all Via Medical Corp. devices

Submission Details

510(k) Number K922997 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received June 22, 1992
Decision Date January 11, 1994
Days to Decision 568 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
440d slower than avg
Panel avg: 128d · This submission: 568d
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.