510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133807Substantially Equivalent

Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control Unit

Gambro Renal Products, Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K133807 is the FDA 510(k) clearance record for MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT, a class II device, cleared for Gambro Renal Products, Inc. on under FDA product code FLD (Apparatus, Hemoperfusion, Sorbent). FDA records list 37 510(k) clearances for Gambro Renal Products, Inc., from to . As of , FDA records show one recall naming K133807.

Clearance record

Decision date
Received
(100 days to decision)
Product code
FLD Apparatus, Hemoperfusion, Sorbent
Regulation
21 CFR 876.5870
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro Renal Products, Inc. 14143 Denver W. Pkwy., Lakewood CO
510(k) summary
Statement
Third party review
No

Clearances, product code FLD

Trailing 12 months

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

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