510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921168Substantially Equivalent

Allen Infusion Pump Model 3000 and Irrigation 2000

Allen Medical Systems, Inc., Bedford Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921168 is the FDA 510(k) clearance record for ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000, a class I device, cleared for Allen Medical Systems, Inc. on under FDA product code KZD (Infusor, Pressure, For I.V. Bags). FDA records list 5 510(k) clearances for Allen Medical Systems, Inc., from to . As of , FDA records show no recalls naming K921168.

Clearance record

Decision date
Received
(407 days to decision)
Product code
KZD Infusor, Pressure, For I.V. Bags
Regulation
21 CFR 880.5420
Device class
Class I
Review panel
General Hospital
Applicant
Allen Medical Systems, Inc. 5198 Richmond Rd., Bedford Heights OH
510(k) summary
Statement
Third party review
No

Clearances, product code KZD

Trailing 12 months

FDA records hold no clearances under product code KZD in the trailing twelve months.

FDA records show no clearances under product code KZD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260