510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K970648Substantially Equivalent

Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350s,2000,2000s)

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

K970648 is the FDA 510(k) clearance record for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S), a class II device, cleared for Renal Systems, Inc. on under FDA product code MSF (Hemodialyzer, Re-Use, High Flux). FDA records list 35 510(k) clearances for Renal Systems, Inc., from to . As of , FDA records show no recalls naming K970648.

Clearance record

Decision date
Received
(319 days to decision)
Product code
MSF Hemodialyzer, Re-Use, High Flux
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Renal Systems, Inc. 14605 28th Ave. N., Minneapolis MN
510(k) summary
Statement
Third party review
No

Clearances, product code MSF

Trailing 12 months

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

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