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Extension Set

by B. Braun Medical, Inc.

510(k) K153293

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153293 Date6 Apr 2016ClearedStatusActive

Recalls

8 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-0674-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0630-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0673-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0612-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0611-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0669-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0665-2026 FDA Class II initiated 29 Oct 2025

    Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

    • Terminated Z-1509-2021 FDA Class II initiated 15 Mar 2021

    BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FPA
FDA applicant
B.Braun Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 880.5440
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

An extension set is a device used to extend infusion and transfusion lines, featuring an in-line injection port and back-check valve. It is designed to allow manipulation away from the injection site and reduce vascular access complications.

The extension set is supplied non-sterile and is intended for single-use. It is available in various lengths and tubing dimensions, with optional 0.2, 1.2, and 5 micron filters. Components are not made with DEHP or latex. It received FDA 510(k) clearance (K153293) as substantially equivalent to a predicate device.

From the manufacturer

Filtered Extension Sets -. B. Braun extension sets are available in various lengths and dimensions to accommodate various applications. B. Braun filtered extension sets include: Available with 0.2, 1.2 and 5 micron filters A range of lengths that provide flexibility in a variety of clinical settings. A variety of tubing dimensions offer flexibility for diverse care settings.

Source: bbraunusa.com

Other devices from B. Braun Medical, Inc.

See all devices from B. Braun Medical, Inc. →

Questions

AI-generated answers, 24 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 extension set used for?

    The extension set is used to extend infusion and transfusion lines, allowing manipulation away from the injection site and helping reduce vascular access complications through its in-line injection port and back-check valve.

  • Is the extension set sterile or non-sterile, and is it reusable?

    The extension set is supplied non-sterile and is intended for single-use only; it should not be reused due to the risk of contamination and compromise of the back-check valve and injection port integrity.

  • What sizes, filters, and materials are available for the extension set?

    The extension set is available in various lengths and tubing dimensions, with optional 0.2, 1.2, and 5 micron filters, and its components are not made with DEHP or latex.