Churchill Female Luer Lock Cap

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

510(k) Number

K861439 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Churchill Haber Point Needle Admin. Set

  Class II

  FDA 510(k) K850420 Active Cleared 24 Apr 1985

• Churchill-Hs Suspended Non-Vented IV Set

  Class II

  FDA 510(k) K854630 Active Cleared 10 Dec 1985

• Churchill-H Extension Tube

  Class II

  FDA 510(k) K854629 Active Cleared 10 Dec 1985

• Churchill Blood Administration Set

  Class II

  FDA 510(k) K864441 Active Cleared 20 Jan 1987

• Churchill-H Vented IV Set W/Metering Chambers

  Class II

  FDA 510(k) K871732 Active Cleared 15 Jun 1987

• Blood Gas Sampler Kit

  Class II

  FDA 510(k) K850958 Active Cleared 10 Apr 1985

See all devices from Churchill Corp. →

• What is the Churchill Female Luer Lock Cap used for?

  The Churchill Female Luer Lock Cap is designed to securely seal and protect the open end of a female luer lock fitting in intravenous or fluid administration systems. It prevents contamination and maintains fluid integrity during storage or transport, ensuring a sterile connection when the system is later used.

• Is this cap sterile and for single-use only?

  Yes, the cap is supplied sterile and intended for single-use in sterile hospital environments. While it can technically be reused for non-sterile applications, its primary purpose is to maintain sterility in clinical settings where fluid pathways must remain uncontaminated.

• How is the cap supplied, and what should I consider for storage?

  The cap is supplied sterile and packaged for single-use. To preserve sterility, store it in its original packaging away from direct sunlight, moisture, or extreme temperatures. Avoid opening or handling the cap until immediate use to prevent contamination.

• Can this cap be used with any female luer lock fitting?

  The cap is designed to fit standard female luer lock fittings commonly used in IV or fluid administration systems. However, compatibility depends on the specific dimensions of the fitting—ensure the cap threads securely without excessive force or slippage to maintain a leak-proof seal.

• What regulatory approval does this cap have, and how was it cleared?

  The cap was cleared by the FDA through a 510(k) submission (K861439) under product code FPA, demonstrating substantial equivalence to a predicate device. It was reviewed by the General Hospital (HO) advisory committee and classified as a traditional clearance.