Extension Sets

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K864692 ↗

FDA Product Code

FPK

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Neonatal Feeding Kit

  Class II

  FDA 510(k) K864683 Active Cleared 17 Apr 1987

• S.C.T. Multi Port, Injection Site

  Class II

  FDA 510(k) K864296 Active Cleared 2 Mar 1987

• Salt Creek P.I. Tray

  Not classified

  FDA 510(k) K864682 Active Cleared 6 Jan 1987

• Scmt Umbilical Clamp

  Class II

  FDA 510(k) K871075 Active Cleared 23 Mar 1987

• I.V. Start Kits

  Not classified

  FDA 510(k) K864693 Active Cleared 16 Dec 1986

• Urine Meter, 250cc

  Class II

  FDA 510(k) K871042 Active Cleared 25 Mar 1987

See all devices from Salt Creek Medical Technologies →

• What are Extension Sets used for in medical settings?

  Extension Sets are tubing devices designed to extend or connect fluid delivery systems in hospital settings. They are classified as Class II medical devices and are intended for general hospital use to facilitate fluid administration.

• How are Extension Sets supplied and what is their regulatory status?

  Extension Sets are supplied by Salt Creek Medical Technologies and are authorized under FDA 510(k) clearance K864692 with product code FPK. They are regulated under number 880.5440 and have received traditional clearance as substantially equivalent devices.

• Are Extension Sets single-use or reusable devices?

  The device data does not specify whether Extension Sets are single-use or reusable. This information would typically be found in the product's instructions for use or labeling, which are not provided in the current device data.

• What sizes and models of Extension Sets are available?

  The device data does not provide specific information about available sizes or models of Extension Sets. The product code FPK indicates the general classification, but detailed specifications regarding lengths, diameters, or specific configurations are not included in the provided information.