Cleared Traditional

K915646 - VIVUS 50 AND VIVUS 100 PERSONAL INFUSER

K915646 is an FDA 510(k) clearance for VIVUS 50 AND VIVUS 100 PERSONAL INFUSER, manufactured by I-Flow Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K915646 · I-Flow Corp. · General Hospital
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Jun 1992
Decision
180d
Days
Class 2
Risk

K915646 is an FDA 510(k) clearance for the VIVUS 50 AND VIVUS 100 PERSONAL INFUSER. 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 June 15, 1992 after a review of 180 days - an extended review 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: 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

FDA 510(k) Submission Details - K915646

510(k) Number K915646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date June 15, 1992
Days to Decision 180 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 129d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K915646.
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · Abbott Laboratories · Apr 1993
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PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K923601 · Abbott Laboratories · Dec 1992
IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE
K921378 · Imed Corp. · Jun 1992
AVI MODEL 470CI INFUSION PUMP
K921072 · 3M Health Care, Ltd. · May 1992
AVI MODEL 480CI INFUSION PUMP
K921073 · 3M Health Care, Ltd. · May 1992