510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872364Substantially Equivalent

Hemodialysis (Sps), Model 550, Code 5M1309

Travenol Laboratories, S.A., Round Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872364 is the FDA 510(k) clearance record for HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309, a class II device, cleared for Travenol Laboratories, S.A. on under FDA product code FII (System, Dialysate Delivery, Sealed). FDA records list 206 510(k) clearances for Travenol Laboratories, S.A., from to . As of , FDA records show 2 recalls naming K872364.

Clearance record

Decision date
Received
(117 days to decision)
Product code
FII System, Dialysate Delivery, Sealed
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Travenol Laboratories, S.A. Wilson Rd. At Rte. 120, Round Lake IL
Third party review
No

Clearances, product code FII

Trailing 12 months

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

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