Cleared Traditional

ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (K921168) - FDA 510(k) Clearance

Class I General Hospital device.

K921168 · Allen Medical Systems, Inc. · General Hospital
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Apr 1993
Decision
407d
Days
Class 1
Risk

K921168 is an FDA 510(k) clearance for the ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Allen Medical Systems, Inc. (Bedford Heights, US). The FDA issued a Cleared decision on April 21, 1993 after a review of 407 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5420 - 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: 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 Allen Medical Systems, Inc. devices

Submission Details

510(k) Number K921168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1992
Decision Date April 21, 1993
Days to Decision 407 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
278d slower than avg
Panel avg: 129d · This submission: 407d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.