Cleared Traditional

K914122 - VITAL INFUSION PUMP

K914122 is an FDA 510(k) clearance for VITAL INFUSION PUMP, manufactured by Vital Resources Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K914122 · Vital Resources Corp. · General Hospital
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Sep 1992
Decision
356d
Days
Class 2
Risk

K914122 is an FDA 510(k) clearance for the VITAL INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Vital Resources Corp. (Rochester Hills, US). The FDA issued a Cleared decision on September 3, 1992 after a review of 356 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Vital Resources Corp. devices

FDA 510(k) Submission Details - K914122

510(k) Number K914122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date September 03, 1992
Days to Decision 356 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
227d slower than avg
Panel avg: 129d · This submission: 356d
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 615
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K914122.
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · Abbott Laboratories · Apr 1993
IVAC SYRINGE PUMP - 740 SERIES
K923981 · Y · Jan 1993
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K923601 · Abbott Laboratories · Dec 1992
DISETRONIC PANOMAT PUMP
K915566 · Disetronic Medical Systems · Aug 1992
VIVUS 50 AND VIVUS 100 PERSONAL INFUSER
K915646 · I-Flow Corp. · Jun 1992
IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE
K921378 · Imed Corp. · Jun 1992