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Administration Sets With Ball Float

by Imed Corp.

510(k) K951922

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK951922 Date19 Jul 1995ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2462-2021 FDA Class II initiated 2 Aug 2021

    Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

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  • Withdrawn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, 23 Sep 2026

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

Administration sets with ball float are medical devices used for the delivery of fluids, such as intravenous solutions, in a controlled manner. The ball float mechanism within the set provides a visual indication of fluid flow rate or level, assisting in monitoring infusion.

These sets are supplied as non-sterile, single-use devices intended for use in general hospital settings. They are not MRI safe and should be stored according to manufacturer specifications. Authorization for this device is based on FDA 510(k) clearance under product code FPA, with K-number K951922.

Other devices from Imed Corp.

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Questions

AI-generated answers, 23 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 purpose of the ball float in these administration sets?

    The ball float mechanism provides a visual indication of fluid flow rate or level, helping clinicians monitor infusion during intravenous fluid delivery.

  • Are these administration sets sterile or non-sterile, and are they reusable?

    These sets are supplied as non-sterile, single-use devices, meaning they are intended for one-time use only and should not be reprocessed or reused.

  • What regulatory pathway was used for the authorization of this device?

    The device received authorization through FDA 510(k) clearance under product code FPA, with K-number K951922, based on a traditional submission found substantially equivalent.