Cleared Traditional

K790945 - MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU

K790945 is the FDA 510(k) clearance for MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU by Vickers America Medical Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K790945 · Vickers America Medical Corp. · General Hospital
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Jun 1979
Decision
14d
Days
Class 2
Risk

K790945 is an FDA 510(k) clearance for the MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Vickers America Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1979 after a review of 14 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vickers America Medical Corp. devices

Submission Details

510(k) Number K790945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1979
Decision Date June 01, 1979
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
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.

Regulatory Peers - FRN Pump, Infusion

All 307
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K790945.
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K792050 · 3M Company · Mar 1980
MODEL IV 6500 FORMULATOR
K792142 · Valleylab, Inc. · Nov 1979
FLEXIFO ENTERAL NUTRITION PUMP
K791528 · Abbott Laboratories · Sep 1979
BLOOD CELL SEPARATOR SYSTEM CS3000
K790315 · Travenol Laboratories, S.A. · May 1979
MODEL IV6000 INFUSION PUMP
K790332 · Valleylab, Inc. · Apr 1979
IVAC 630 VOLUMETRIC INFUSION PUMP
K790373 · Y · Apr 1979