Cleared Traditional

K921168 - ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000

K921168 is an FDA 510(k) clearance for ALLEN INFUSION PUMP MODEL 3000 AND IRRI..., manufactured by Allen Medical Systems, Inc.. The device is a Class 1 General Hospital device with product code KZD cleared through the Traditional 510(k) pathway after a 407-day FDA review.

K921168 · Allen Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K921168

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.

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 16
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K921168.
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · Olympus America, Inc. · Oct 1995
PRESSURIZER
K951988 · Promedic, Inc. · Jun 1995
KAWASUMI LABORATORIES K-CUFF
K930012 · Kawasumi Laboratories Co., Ltd. · Dec 1993
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · Abbott Laboratories · Aug 1990
SURGI SQUEEZ
K894927 · Ethox Corp. · Sep 1989
DATA TRAC ANESTHESIOLOGY RECORDER
K851904 · Datascope Corp. · May 1985