Churchill-HS Suspended Vented IV Set

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

510(k) Number

K854627 ↗

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-HS Suspended Vented IV Set used for?

  This device is specifically designed for intravenous administration in hospital settings. Its suspended and vented configuration helps control fluid flow while significantly reducing the risk of air entering the infusion system, which lowers the chance of air embolism during therapy. It is classified under the product code FPA for administration sets.

• Is the Churchill-HS Suspended Vented IV Set sterile and single-use?

  Yes, the Churchill-HS Suspended Vented IV Set is supplied sterile and packaged for clinical use. It is intended for single-use only, adhering to standard aseptic protocols for intravenous administration sets in hospital environments. This ensures patient safety and compliance with regulatory standards.

• What regulatory clearance does this IV set have?

  The Churchill-HS Suspended Vented IV Set received a Traditional 510(k) clearance (K854627) from the FDA in 1985 under a Substantially Equivalent (SESE) determination. It is classified as a Class II device and complies with FDA Regulation 880.5440. No third-party review was required for this clearance.

• How should the Churchill-HS Suspended Vented IV Set be stored?

  Storage and handling of this IV set follow standard aseptic protocols for intravenous administration sets. It should be kept in its original, unopened packaging until ready for use to maintain sterility. Ensure the environment is clean and free from contamination to prevent compromising the device’s integrity.

• What advisory committee reviewed this device?

  The Churchill-HS Suspended Vented IV Set was reviewed by the General Hospital advisory committee under the FDA’s classification system. This committee evaluates devices intended for use in general hospital settings, ensuring they meet safety and performance standards for clinical applications.