510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955497Substantially Equivalent

Gambro Fh 22H Fiber Hemofltr/prisma Fh 22H Blood Tubing/hemofltr Set

Cobe Renal Care, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955497 is the FDA 510(k) clearance record for GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET, a class II device, cleared for Cobe Renal Care, Inc. on under FDA product code KDL (Set, Perfusion, Kidney, Disposable). FDA records list 14 510(k) clearances for Cobe Renal Care, Inc., from to . As of , FDA records show no recalls naming K955497.

Clearance record

Decision date
Received
(664 days to decision)
Product code
KDL Set, Perfusion, Kidney, Disposable
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cobe Renal Care, Inc. 4503 Moorland Ave., Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code KDL

Trailing 12 months

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

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