Allen Infusion Pump Model 3000 and Irrigation 2000

Q: What is the product code of K921168?

The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.

FDA 510(k) K921168 · Allen Medical Systems, Inc.

Substantially Equivalent

510(k) numberK921168

Submission

Device name: Allen Infusion Pump Model 3000 and Irrigation 2000
Applicant: Allen Medical Systems, Inc.
Bedford Heights, OH, US
Received: March 10, 1992
Decision date: April 21, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: KZD – Infusor, Pressure, For I.V. Bags
Device class: Class I (low risk)
Regulation: 21 CFR 880.5420
Specialty: General Hospital

Other 510(k)s with product code KZD

510(k)	Device	Applicant	Decision
K974074	Infusion Dynamics Power InfuserKZD · Traditional	Infusion Dynamics, Inc.	02/17/1998SE
K973843	Msi Pressure InfusorKZD · Traditional	Smith Assoc.	10/29/1997SE
K953290	Olympus Automatic Surgical Irrigation PumpKZD · Traditional	Olympus America, Inc.	10/07/1995SE
K951988	PressurizerKZD · Traditional	Promedic, Inc.	06/14/1995SE
K942933	Pressure Infusion CuffKZD · Traditional	Circulatory Technology, Inc.	08/25/1994SE
K930012	Kawasumi Laboratories K-CuffKZD · Traditional	Kawasumi Laboratories Co., Ltd.	12/14/1993SE
K913751	Pressure InfuserKZD · Traditional	Biomedical Dynamics, Inc.	01/09/1992SE
K910926	Tecnadyne Surgi-Squeeze Infusion PumpKZD · Traditional	Tecnadyne Scientific, Inc.	08/02/1991SE
K911216	InfusableKZD · Traditional	Biomedical Dynamics, Inc.	07/22/1991SE
K904484	Baxter Single Patient Use Pressure InfusorKZD · Traditional	Tecnadyne Scientific, Inc.	10/26/1990SE

More from Tecnadyne Scientific, Inc.

510(k)	Device	Decision
K971988	Allen, Ultra and Smart SocketsFQO · Traditional	07/11/1997SE
K964273	Dura-Board ArmboardGDC · Traditional	01/08/1997SE
K960027	High Volume I.V. & Irrigation TowerFOX · Traditional	03/12/1996SE
K944779	Carbon Lights Hand Surgery TableFWZ · Traditional	10/14/1994SE

Questions and answers

When was Allen Infusion Pump Model 3000 and Irrigation 2000 cleared by the FDA?

Allen Infusion Pump Model 3000 and Irrigation 2000 (K921168) received a 510(k) decision of Substantially Equivalent on April 21, 1993, 407 days after the submission was received.

What is the product code of K921168?

The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.