Cleared Traditional

K935778 - VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM

K935778 is an FDA 510(k) clearance for VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY ..., manufactured by Via Medical Corp.. The device is a Class 2 Anesthesiology device with product code CCE cleared through the Traditional 510(k) pathway after a 1098-day FDA review.

K935778 · Via Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
1098d
Days
Class 2
Risk

K935778 is an FDA 510(k) clearance for the VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Via Medical Corp. (San Diego, US). The FDA issued a Cleared decision on December 5, 1996 after a review of 1098 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1200 - the FDA anesthesiology and respiratory 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 Anesthesiology submissions.

View all Via Medical Corp. devices

FDA 510(k) Submission Details - K935778

510(k) Number K935778 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 03, 1993
Decision Date December 05, 1996
Days to Decision 1098 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
958d slower than avg
Panel avg: 140d · This submission: 1098d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCE Device Classification - Class 2, Special Controls

Product Code CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1200
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

All 15
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K935778.
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
K912145 · S & W Medico Teknik · May 1992
TOPS NEEDLE TIP PROBE & PVC TIP PROBE
K910453 · Baxter Healthcare Corp · Aug 1991
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
K905397 · Puritan Bennett Corp. · May 1991
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
K890624 · Baxter Healthcare Corp · Dec 1989
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K895149 · Shiley, Inc. · Nov 1989
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
K895150 · Shiley, Inc. · Nov 1989