Primary Admin Set W/Univ Sp-Man Below/Abv Pump Ch

• • Ongoing Z-2463-2021 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.

• 2 recalls, same reason

  • Terminated Z-1121-2019 FDA Class II ·initiated 5 Mar 2019
  • Terminated Z-1120-2019 FDA Class II ·initiated 5 Mar 2019

  The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

510(k) Number

K931173 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• The Imed Ambulatory Infusion Pump, Administration Sets

  Class II

  FDA 510(k) K953896 Active Cleared 20 Mar 1996

• Macrodot Add-I-Med Admin. Set

  Class II

  FDA 510(k) K823347 Active Cleared 24 Nov 1982

• Imed Gemini 12 Nonvented Y-Type Blood/Solution Adm

  Class II

  FDA 510(k) K894842 Active Cleared 12 Sep 1989

• Imed(R) Gemini(Tm) Pc-1 Volumetric Infusion Pump

  Class II

  FDA 510(k) K880479 Active Cleared 25 Apr 1988

• IV Filterset 5 Micrometer

  Class II

  FDA 510(k) K813445 Active Cleared 5 Jan 1982

• Imed Accuset Cassette

  Class II

  FDA 510(k) K812035 Active Cleared 28 Jul 1981

See all devices from Imed Corp. →

• What is the Primary Admin Set With Universal Spiking Manifold designed to do in a clinical setting?

  This device is an intravascular administration set designed to connect a fluid container (like IV bags) to a patient’s vein through a needle or catheter. The universal spiking manifold is specifically configured to work either below or above an infusion pump, allowing compatibility with multiple pump systems to deliver fluids, medications, or nutrients safely into the vascular system.

• Is this administration set reusable, or is it meant for single-use only?

  The Primary Admin Set With Universal Spiking Manifold is explicitly intended for single-use only. It is supplied sterile, and reuse could compromise sterility and patient safety, so adherence to single-use protocols is required.

• How should this device be stored to maintain its sterility and functionality?

  Since this is a sterile medical device, it must be stored according to standard sterile medical device protocols. This typically includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until immediate use.

• What regulatory pathway does this device follow, and how does it compare to similar products?

  This device follows the FDA 510(k) clearance pathway, with clearance number K931173. It is classified as substantively equivalent to a predicate device, meaning its design and performance are deemed comparable to an already-approved product in the same category (intravascular administration sets). The product code FPA aligns with regulatory classification 880.5440 under the General Hospital specialty.