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IV Administration

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142622

by Hospira, Inc.

Identifiers

510(k) Number
K142622 FDA 510(k)
FDA Product Code
FPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is classified as an Intravenous Administration Set (FDA Product Code: FPA), designed for the controlled delivery of fluids, medications, or nutrients directly into a patient’s venous system. It facilitates precise infusion rates and ensures compatibility with single-fluid regimens via intravenous, subcutaneous, or arterial routes, supporting a range of clinical applications including patient-controlled analgesia (PCA) when configured with appropriate accessories.

The IV Administration Set is supplied as a single-use, non-sterile device (unless specified otherwise in sterile packaging) and is intended for use in hospital or clinical settings. It is regulated under FDA 510(k) clearance (K142622) as substantially equivalent to predicate devices, with no explicit MRI safety classification noted. Storage and handling follow standard aseptic practices, and its design adheres to general hospital use guidelines as per the HO Advisory Committee review. No additional regulatory markings beyond the FDA clearance are provided in the specifications.

Frequently asked questions

What clinical scenarios is this IV Administration Set primarily designed for, and how does it support those uses?

This IV Administration Set is designed for controlled delivery of fluids, medications, or nutrients through intravenous, subcutaneous, or arterial routes. It supports a variety of clinical applications, including standard fluid infusions and patient-controlled analgesia (PCA) when paired with compatible accessories. Its precise flow control makes it suitable for single-fluid regimens, ensuring accurate dosing in hospital or clinical settings.

Is this IV Administration Set intended for reuse, or is it meant to be used only once? How does this affect its handling?

This IV Administration Set is explicitly labeled as a single-use device. Because it is non-sterile unless supplied in sterile packaging, it must be discarded after one use to maintain patient safety and prevent contamination. Proper disposal follows standard hospital protocols for medical waste to avoid reuse or cross-contamination.

What storage and handling precautions should be taken with this IV Administration Set before use?

The IV Administration Set should be stored and handled according to standard aseptic practices to ensure sterility (if packaged sterile) or cleanliness (if non-sterile). Avoid exposure to extreme temperatures, moisture, or direct sunlight, as these can compromise the integrity of the tubing or connectors. Always check the packaging for expiration dates or damage before use, and follow manufacturer guidelines for preparation to prevent contamination.

How is this device regulated, and what does the FDA’s clearance status mean for its use in hospitals?

This IV Administration Set received FDA 510(k) clearance (K142622) under the Traditional Review pathway, with a decision of Substantially Equivalent (SESE) to predicate devices. This means it meets FDA standards for safety and effectiveness as determined by the Hospital Devices (HO) Advisory Committee, ensuring it complies with general hospital-use requirements. Hospitals may rely on this clearance to confirm its suitability for controlled infusion applications, though clinical protocols should still align with institutional policies.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hospira Manuals & User Guides - Manuals+, PDF HOSPIRA, PDF EPS-95215-004 (B) - outfrontmedical.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hospira, Inc.

Sources (1)

  • FDA 510(k) K142622 24 fields · synced Sep 18, 2026