510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K941803Unknown

Prism Medical Custom Dialysis Kit

Medical Device Support Services, El Paso TX / Traditional, Unknown
FDA source (opens on fda.gov)

K941803 is the FDA 510(k) clearance record for PRISM MEDICAL CUSTOM DIALYSIS KIT, a class II device, cleared for Medical Device Support Services on under FDA product code KOC (Accessories, Blood Circuit, Hemodialysis). FDA records list one 510(k) clearance for Medical Device Support Services. As of , FDA records show no recalls naming K941803.

Clearance record

Decision date
Received
(293 days to decision)
Product code
KOC Accessories, Blood Circuit, Hemodialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medical Device Support Services 4840 Portsmouth Blvd., El Paso TX
510(k) summary
Summary
Third party review
No

Clearances, product code KOC

Trailing 12 months

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

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