510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K143446Substantially Equivalent

Accu-Chek FlexLink Plus infusion set

Roche Diagnostics GmbH, Mannheim, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143446 is the FDA 510(k) clearance record for Accu-Chek FlexLink Plus infusion set, a class II device, cleared for Roche Diagnostics GmbH on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 465 510(k) clearances for Roche Diagnostics GmbH, from to . As of , FDA records show no recalls naming K143446.

Clearance record

Decision date
Received
(254 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260