NFC Needlefree Y-Site, Model 69970

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

510(k) Number

K981547 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Nfc Needlefree Connector Model 69900

  Class II

  FDA 510(k) K981548 Active Cleared 18 Jun 1998

• Transducer Protector

  Class II

  FDA 510(k) K895281 Active Cleared 8 Nov 1989

• I.V. Extender Set

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  FDA 510(k) K911451 Active Cleared 6 Jun 1991

• I.V. Filter Extension Set

  Class II

  FDA 510(k) K912848 Active Cleared 29 Nov 1991

• Pn 62290 0.22 Micron Micro Infus I.V. Exten Set

  Class II

  FDA 510(k) K914792 Active Cleared 15 Jan 1992

• Filtertek Pn 60650 Dialysis Transducer Protector

  Class II

  FDA 510(k) K901996 Active Cleared 1 Jun 1990

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• What is the NFC Needlefree Y-Site 69970 used for?

  The NFC Needlefree Y-Site 69970 is designed for intravenous (IV) fluid administration, allowing simultaneous infusion of multiple fluids or medications without needle insertion. This reduces patient discomfort and lowers infection risk by eliminating the need for repeated needle sticks during fluid transitions.

• How is the NFC Needlefree Y-Site 69970 supplied and stored?

  The device comes in a sterile Twek/polyethylene package, ensuring sterility upon receipt. It must be stored according to sterile medical device protocols to maintain its integrity and functionality. Always handle it with care to avoid contamination, and use it only once per patient.

• Is the NFC Needlefree Y-Site 69970 reusable or single-use?

  This device is intended for single-use only. Reusing it violates sterile medical device protocols and could compromise patient safety by introducing contamination or material degradation. Always discard after one use.

• What materials is the NFC Needlefree Y-Site 69970 made from, and is it non-pyrogenic?

  The device is constructed from materials that meet tripartite testing guidelines for material safety and is explicitly labeled as non-pyrogenic. This ensures it won’t induce fever or adverse reactions during use, making it suitable for general hospital settings.

• How do I verify the regulatory compliance of the NFC Needlefree Y-Site 69970?

  The device holds FDA 510(k) clearance (K981547) as substantially equivalent to a predicate product, confirming its compliance with U.S. regulatory standards. The clearance was granted under the General Hospital product code (FPA) and reviewed by the Orthopaedics (HO) Advisory Committee in 1998. Always reference the FDA’s official database for the most current status.