Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set— 510(k) K173651

Clearance details

Applicant

Fresenius Medical Care Renal Therapies Group, LLC

Product code

Code KDJ

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

2017-11-28

Decision date

2018-02-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Waltham, MA, US

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Death

298

Injury

9,221

Malfunction

8,438

Other

1

Total

17,958

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-2089-2021 — The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.Class II·Terminated·Fresenius Medical Care Holdings, Inc.·20210428

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173651.