510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912208Substantially Equivalent

Fresenius Safe-Connect Capd Manual Assist Device

Fresenius USA, Inc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912208 is the FDA 510(k) clearance record for FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE, a class II device, cleared for Fresenius USA, Inc. on under FDA product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable). FDA records list 38 510(k) clearances for Fresenius USA, Inc., from to . As of , FDA records show no recalls naming K912208.

Clearance record

Decision date
Received
(65 days to decision)
Product code
KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fresenius USA, Inc. 4090 Pike Ln., Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code KDJ

Trailing 12 months

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

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