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Extended Life CAPD Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap

by Baxter Healthcare

510(k) K152675

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

13 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152675 Date29 Oct 2015ClearedStatusActive

Recalls

13 recalls · 13 ongoing · FDA

    • Ongoing Z-0559-2025 FDA Class II initiated 23 Oct 2024

    There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

    • Ongoing Z-0373-2025 FDA Class I initiated 21 Oct 2024

    Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

  • 11 recalls, same reason

    • Ongoing Z-0580-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0576-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0579-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0574-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0571-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0570-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0578-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0577-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0575-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0572-2022 FDA Class II initiated 7 Jan 2022
    • Ongoing Z-0573-2022 FDA Class II initiated 7 Jan 2022

    Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter
510(k) Number
FDA Product Code
KDJ
Device Class
Class II
Regulation
21 CFR Part 876.5630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Set, Administration, For Peritoneal Dialysis, Disposable, designed for continuous ambulatory peritoneal dialysis (CAPD). It facilitates the transfer of peritoneal dialysis solution between the patient’s catheter and the solution container, ensuring secure and aseptic connections during therapy.

The set includes a female locking connector, on-off clamp, tubing, and a double sealing male Luer lock connector, intended for use with the Baxter Locking Titanium Adapter. Supplied as a single-use, sterile device, it is regulated under FDA 510(k) clearance (K152675) and falls under Class II medical devices (regulation number 876.5630). Multiple reference codes (e.g., 3038277270, 3001239013) identify compatible configurations for peritoneal dialysis applications.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of this device in peritoneal dialysis treatment?

    This device is designed specifically for continuous ambulatory peritoneal dialysis (CAPD) to facilitate the transfer of dialysis solution between the patient’s catheter and the solution container. It ensures secure, aseptic connections during therapy by including components like a female locking connector, on-off clamp, and tubing, all intended to maintain sterility and functionality throughout the procedure.

  • Is this transfer set intended for single-use or can it be reused?

    The device is explicitly labeled as a single-use, sterile transfer set. Reuse is not recommended or supported, as it could compromise sterility and patient safety during peritoneal dialysis.

  • What specific catheter adapter does this transfer set require for compatibility?

    This transfer set is designed for use with the Baxter Locking Titanium Adapter, which includes a double-sealing male Luer lock connector. The set’s components (female locking connector, tubing, and clamp) are engineered to interface securely with this adapter to prevent leaks and contamination during dialysis exchanges.

  • How many different configurations or product codes are associated with this transfer set?

    The device is available in multiple configurations, each identified by unique FEI numbers (e.g., 3038277270, 3001239013) and registration numbers (e.g., 1058584). These codes correspond to variations in tubing lengths, connector types, or other minor specifications tailored for peritoneal dialysis applications, ensuring compatibility with different patient setups.

  • What regulatory pathway was followed for FDA clearance of this device?

    This transfer set received FDA 510(k) clearance under the traditional review pathway (K152675) and is classified as a Class II medical device (regulation number 876.5630). The submission was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, with a decision of Substantially Equivalent (SESE) made on October 29, 2015.