510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800560Substantially Equivalent

Mx820-5 Pressure Infusor 500Cc Mx820-10

Medex, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800560 is the FDA 510(k) clearance record for MX820-5 PRESSURE INFUSOR 500CC MX820-10, a class I device, cleared for Medex, Inc. on under FDA product code KZD (Infusor, Pressure, For I.V. Bags). FDA records list 3 510(k) clearances for Medex, Inc., from to . As of , FDA records show no recalls naming K800560.

Clearance record

Decision date
Received
(48 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
Medex, Inc. 4221 Richmond Rd., NW, Walker MI
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