Hypodermic Needles, Single Lumen (K874414)

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

Full name

Hypodermic Needles, Single Lumen

510(k) Number

K874414 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Harbor Central Venous Catheter

  Class II

  FDA 510(k) K881884 Active Cleared 28 Jul 1988

• Sea - Port Infusion Set

  Class II

  FDA 510(k) K880297 Active Cleared 19 Feb 1988

• S.E.A.-Port(Tm) Vascular Access System

  Class II

  FDA 510(k) K882190 Active Cleared 9 Jun 1988

• Harbor S.E.A.-Port Surgical Accessory Kit

  Class II

  FDA 510(k) K882657 Active Cleared 13 Dec 1988

• Harborin Central Venous Catheter

  Class II

  FDA 510(k) K884628 Active Cleared 15 May 1989

• Single Lumen S.E.a.-Port Vascular Access System

  Class II

  FDA 510(k) K890518 Active Cleared 21 Apr 1989

• What is the primary use of these single-lumen hypodermic needles?

  These needles are designed for injecting fluids into or withdrawing fluids from subcutaneous body tissues. Their single-lumen design ensures precise administration or extraction of substances, making them suitable for general hospital procedures like injections, blood draws, or intravenous access.

• Are these needles intended for reuse or single-use?

  These needles are explicitly intended for single-use only. They are supplied in sterile packaging to maintain hygiene and safety standards, preventing cross-contamination and ensuring reliable performance for one-time clinical procedures.

• How should these needles be stored to maintain sterility?

  Storage must follow standard medical device protocols to preserve sterility and functionality. Keep the sealed, sterile packaging intact until immediate use. Avoid exposure to moisture, extreme temperatures, or direct sunlight, and store in a clean, dry environment as recommended for disposable medical devices.

• What types of syringes or infusion systems are compatible with these needles?

  The needles are designed with a hub that connects to complementary syringes or infusion systems commonly used in clinical settings. Their compatibility aligns with standard medical infusion practices, ensuring seamless integration with widely available equipment for injections or fluid extraction.

• What regulatory clearance does this device hold, and what does that mean for its use?

  This device holds FDA 510(k) clearance (K874414) with a decision of Substantially Equivalent (SESE). This means the device has been reviewed by the FDA and determined to be as safe and effective as a legally marketed predicate device, allowing its use in clinical environments under standard sterile, disposable protocols.