\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR— 510(k) K022536

Clearance details

Applicant

Fresenius Medical Care

Product code

Code KOC

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

2002-08-01

Decision date

2002-10-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lexington, MA, US

• K242176 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)2025-05-15
• K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU2025-05-15
• K231589 — Blood Tubing Lines for Hemodialysis AV06C-E2023-07-28
• K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series2023-06-16
• K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line2020-09-18

• K231534 — 5008X Hemodialysis System2024-02-02
• K141997 — CRIT-LINE IV SYSTEM2015-04-01
• K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINE2011-10-21
• K030497 — FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES2003-05-20
• K023162 — FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS2003-03-20

Death

4

Total

4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1047-2015 — Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.Class II·Terminated·Fresenius Medical Care Holdings, Inc.·20141219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022536.