Cleared Traditional

K940406 - DISPOSABLE, AMBULATORY, INFUSION PUMPS

K940406 is an FDA 510(k) clearance for DISPOSABLE, manufactured by Vlv Associates, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K940406 · Vlv Associates, Inc. · General Hospital
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Sep 1994
Decision
218d
Days
Class 2
Risk

K940406 is an FDA 510(k) clearance for the DISPOSABLE, AMBULATORY, INFUSION PUMPS. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Vlv Associates, Inc. (East Hanover, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 218 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 Vlv Associates, Inc. devices

FDA 510(k) Submission Details - K940406

510(k) Number K940406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 27, 1994
Decision Date September 02, 1994
Days to Decision 218 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
89d slower than avg
Panel avg: 129d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 42
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K940406.
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K913658 · Imed Corp. · Mar 1992