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Maxplus Tru-Swab Positive Displacement Connector

by Medegen Medical Manufacturing System 2 variants

510(k) K051939

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051939 Date1 Aug 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
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.

The Maxplus Tru-Swab Positive Displacement Connector is a sterile single patient use positive displacement connector for needleless access to the IV line and/or IV catheter during IV therapy. It features Tru-Swab® technology providing a flat, smooth surface free of gaps, slits or intricate surfaces, and contains no metal, making it safe for MRI environments.

The device is lipid- and chemo-compatible, tested to 325 psi with a flow rate of 10 mL/sec, and its dual seal design helps reduce microbial ingress. Positive displacement helps prevent reflux at disconnect, aiding in maintaining a patent line. It is supplied sterile for single-use and is authorized under FDA 510(k) clearance K051939 with product code FPA.

Other devices from Medegen Medical Manufacturing System

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 Maxplus Tru-Swab Positive Displacement Connector used for?

    The Maxplus Tru-Swab Positive Displacement Connector is a sterile single patient use device designed for needleless access to the IV line and/or IV catheter during IV therapy. It helps maintain a patent line by preventing reflux at disconnect through its positive displacement mechanism and features a dual seal design to reduce microbial ingress.

  • Is the Maxplus Tru-Swab Positive Displacement Connector sterile and intended for single use?

    Yes, the device is supplied sterile and is designated for single patient use only. It is not intended for reuse, as specified in its description as a sterile single patient use positive displacement connector.

  • What materials and design features make the Maxplus Tru-Swab connector suitable for MRI environments?

    The connector contains no metal, which makes it safe for use in MRI environments. It also features Tru-Swab® technology that provides a flat, smooth surface free of gaps, slits, or intricate surfaces, reducing areas where contaminants could accumulate.

  • What performance specifications are provided for the Maxplus Tru-Swab Positive Displacement Connector?

    The device is lipid- and chemo-compatible, tested to withstand 325 psi, and has a flow rate of 10 mL/sec. These specifications support its use in demanding IV therapy environments involving viscous medications or high-pressure injections.

  • How was the Maxplus Tru-Swab Positive Displacement Connector authorized for market release?

    The device was authorized under FDA 510(k) clearance with the number K051939 and is classified under product code FPA. The authorization was based on a determination of substantial equivalence to a predicate device through a traditional 510(k) submission.