Medi-Plast 2 Port Manifold (Right On)

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

510(k) Number

K954284 ↗

FDA Product Code

DTL

Device Class

Class II

Regulation

21 CFR Part 870.4290

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 10CC Control Syringe

  Class II

  FDA 510(k) K873588 Active Cleared 23 Oct 1987

• Arterial-Venous Compression Dressing

  Not classified

  FDA 510(k) K851489 Active Cleared 11 Jun 1985

• I.V. Bottle (Ridgid) Open recall

  Class II

  FDA 510(k) K811234 Active Cleared 18 Jun 1981

• Glass Vials Open recall

  Class II

  FDA 510(k) K811269 Active Cleared 16 Jun 1981

• Fluoroscope Band Bag

  Class II

  FDA 510(k) K861785 Active Cleared 13 Jun 1986

• Operating Room Tray Set

  Class I

  FDA 510(k) K840021 Active Cleared 15 Mar 1984

See all devices from Medi-Plast Intl., Inc. →

• What is the primary purpose of the Medi-Plast 2 Port Manifold?

  This device functions as a cardiopulmonary bypass adaptor, stopcock, or fitting. It is designed to interconnect tubing, catheters, and other medical devices during cardiovascular diagnostic, surgical, and therapeutic applications.

• How is this device classified by the FDA?

  The Medi-Plast 2 Port Manifold is classified as a Class II medical device under regulation number 870.4290. It received FDA 510(k) clearance under the submission number K954284.

• What is the regulatory status of this manifold?

  The device has received FDA 510(k) clearance, which indicates that the manufacturer demonstrated the device is substantially equivalent to a legally marketed predicate device.