Cleared Traditional

VIVUS 5000 INFUSION SYSTEM (K924527) - FDA 510(k) Clearance

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

K924527 · I-Flow Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
567d
Days
Class 2
Risk

K924527 is an FDA 510(k) clearance for the VIVUS 5000 INFUSION SYSTEM. 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 March 29, 1994 after a review of 567 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 I-Flow Corp. devices

Submission Details

510(k) Number K924527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1992
Decision Date March 29, 1994
Days to Decision 567 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
438d slower than avg
Panel avg: 129d · This submission: 567d
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 K924527.
ABBOTT LTE INFUSION PUMP
K944125 · Abbott Laboratories · Dec 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
BARD APII PUMP
K926385 · C.R. Bard, Inc. · Apr 1994
HI-FLO INFUSION PUMP
K934671 · Abbott Laboratories · Mar 1994
BARD 500ML RESERVOIR HOLDER
K915649 · C.R. Bard, Inc. · Mar 1994
KVOI.V. FLUSH SYSTEM
K923224 · Baxter Healthcare Corp · Feb 1994