Cleared Traditional

K874454 - IV-PUSH, CONSTANT INFUSION PUMP

K874454 is an FDA 510(k) clearance for IV-PUSH, manufactured by Medical Products Search, Inc.. The device is a Class 1 General Hospital device with product code KZD cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K874454 · Medical Products Search, Inc. · General Hospital
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Nov 1987
Decision
9d
Days
Class 1
Risk

K874454 is an FDA 510(k) clearance for the IV-PUSH, CONSTANT INFUSION PUMP. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Medical Products Search, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5420 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K874454

510(k) Number K874454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date November 06, 1987
Days to Decision 9 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

KZD Device Classification - Class 1, General Controls

Product Code KZD Infusor, Pressure, For I.v. Bags
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KZD Infusor, Pressure, For I.v. Bags

All 34
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K874454.
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · Abbott Laboratories · Aug 1990
SURGI SQUEEZ
K894927 · Ethox Corp. · Sep 1989
PRESSURE INFUSOR
K881977 · Primrose Medical, Inc. · Jul 1988
BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR
K861977 · Biomedical Dynamics, Inc. · Jul 1986
LIFE PAC
K854807 · Lifemed Technologies, Inc. · Apr 1986
THE WOOD PUMP 'OLE RED'
K855054 · T.C. Retigo, Inc. · Mar 1986
K874454 · IV-PUSH, CONSTANT INFUSION PUMP
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