Cleared Traditional

VIVUS PS (PROGRAMMING SOFTWARE) (K913907) - FDA 510(k) Clearance

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

K913907 · I-Flow Corp. · General Hospital
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Dec 1991
Decision
105d
Days
Class 2
Risk

K913907 is an FDA 510(k) clearance for the VIVUS PS (PROGRAMMING SOFTWARE). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by I-Flow Corp. (Irvine, US). The FDA issued a Cleared decision on December 13, 1991 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 I-Flow Corp. devices

Submission Details

510(k) Number K913907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1991
Decision Date December 13, 1991
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 236
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K913907.
FLO-GARD(R) 6201
K915522 · Baxter Healthcare Corp · Feb 1992
FLO-GARD(R) 6301
K915523 · Baxter Healthcare Corp · Feb 1992
PROVIDER APM INFUSION PUMP
K914349 · Abbott Laboratories · Dec 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · Abbott Laboratories · Oct 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · Abbott Laboratories · Oct 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · Abbott Laboratories · Oct 1991