Home / 510(k) Clearances / K921168

510(k) K921168

ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 by Allen Medical Systems, Inc. — Product Code KZD

K921168 is an FDA 510(k) premarket notification submitted by Allen Medical Systems, Inc. for the device "ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000". The FDA issued a decision of Substantially Equivalent on April 21, 1993. The device falls under product code KZD (Infusor, Pressure, For I.V. Bags), a Class I device regulated under 21 CFR 880.5420. Allen Medical Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1993
Date Received
March 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infusor, Pressure, For I.V. Bags
Device Class
Class I
Regulation Number
880.5420
Review Panel
HO
Submission Type

Other clearances by Allen Medical Systems, Inc.

  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K964273 — DURA-BOARD ARMBOARD (January 8, 1997)
  • K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER (March 12, 1996)
  • K944779 — CARBON LIGHTS HAND SURGERY TABLE (October 14, 1994)

Other clearances for product code KZD

  • K974074 — INFUSION DYNAMICS POWER INFUSER (February 17, 1998)
  • K973843 — MSI PRESSURE INFUSOR (October 29, 1997)
  • K953290 — OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP (October 7, 1995)
  • K951988 — PRESSURIZER (June 14, 1995)
  • K942933 — PRESSURE INFUSION CUFF (August 25, 1994)
  • K930012 — KAWASUMI LABORATORIES K-CUFF (December 14, 1993)
  • K913751 — PRESSURE INFUSER (January 9, 1992)
  • K910926 — TECNADYNE SURGI-SQUEEZE INFUSION PUMP (August 2, 1991)
  • K911216 — INFUSABLE (July 22, 1991)
  • K904484 — BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (October 26, 1990)

FDA data resources