510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960027Substantially Equivalent

High Volume i.v. & Irrigation Tower

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

K960027 is the FDA 510(k) clearance record for HIGH VOLUME I.V. & IRRIGATION TOWER, a class I device, cleared for Allen Medical Systems, Inc. on under FDA product code FOX (Stand, Infusion). FDA records list 5 510(k) clearances for Allen Medical Systems, Inc., from to . As of , FDA records show no recalls naming K960027.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FOX Stand, Infusion
Regulation
21 CFR 880.6990
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 FOX

Trailing 12 months

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

FDA records show no clearances under product code FOX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FOX, 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