PBC Needle

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

510(k) Number

K813649 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Intravenous Injection Set

  Class II

  FDA 510(k) K841717 Active Cleared 23 Jul 1984

• Jms Needle & Mac Ject

  Class II

  FDA 510(k) K813648 Active Cleared 28 Jan 1982

• Pbc Syringe Irrigating

  Class II

  FDA 510(k) K834256 Active Cleared 23 Mar 1984

• Pbc IV Set Non-Vented

  Class II

  FDA 510(k) K834253 Active Cleared 27 Feb 1984

• PBC Needle by Nipro Med Industries

  Class II

  FDA 510(k) K820911 Active Cleared 15 Apr 1982

• Pbc Extension Set

  Class II

  FDA 510(k) K834252 Active Cleared 27 Feb 1984

See all devices from Philadelphia Biologics Center →

• What types of injections can the PBC Needle be used for in a hospital setting?

  The PBC Needle is designed for subcutaneous, intramuscular, or intravenous injections in general hospital environments. Its single-lumen, disposable design ensures precise fluid administration or withdrawal while minimizing patient discomfort and infection risk.

• Is the PBC Needle intended for reuse, or is it meant to be used only once?

  The PBC Needle is explicitly designed for single-use only. Its sterile, disposable construction prevents contamination and ensures patient safety, making reuse unsafe and contraindicated.

• How should the PBC Needle be stored to maintain its sterility?

  To preserve sterility, the PBC Needle must be stored in a clean, dry environment away from direct light or moisture. Proper storage prevents degradation and contamination, ensuring the needle remains ready for its intended single-use application.

• What regulatory pathway was followed for FDA clearance of the PBC Needle, and what does that mean for its use?

  The PBC Needle received FDA 510(k) clearance (K813649) under the Traditional 510(k) review pathway, classified under product code FMI for general hospital use. This means it was determined to be substantially equivalent to a legally marketed predicate device, confirming its compliance with safety and performance standards for its intended injection applications.