TS-1800 Medication Transfer Spike

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

510(k) Number

K900651 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Combi-Cap

  Class II

  FDA 510(k) K892428 Active Cleared 14 Jul 1989

• Injection Port II --- for Intermittent Injection

  Class II

  FDA 510(k) K896291 Active Cleared 1 Dec 1989

• Transfeer Spike II

  Class II

  FDA 510(k) K952242 Active Cleared 15 Sep 1995

• Injection Port for---Intermittent Injection

  Class II

  FDA 510(k) K892429 Active Cleared 25 Jul 1989

• Chemo-Spike Reconstitution Device

  Class II

  FDA 510(k) K895290 Active Cleared 27 Dec 1989

• IV Dispesnsing Spike

  Class II

  FDA 510(k) K895291 Active Cleared 27 Dec 1989

See all devices from The Medi-Dose Group →

• What is the TS-1800 Medication Transfer Spike used for?

  The TS-1800 Medication Transfer Spike is designed for transferring medication or diluent between rubber stoppered containers, featuring a double spike design that enables rapid transfer of substances in hospital settings.

• How is the TS-1800 Medication Transfer Spike supplied?

  The TS-1800 Medication Transfer Spike is supplied by The Medi-Dose Group, a manufacturer based in Feasterville, PA, with the address 1671 Loretta Ave.

• What regulatory clearance has the TS-1800 Medication Transfer Spike received?

  The TS-1800 Medication Transfer Spike received FDA 510(k) clearance on May 7, 1990, with product code FPA, and was determined to be substantially equivalent to predicate devices.

• Is the TS-1800 Medication Transfer Spike reusable or single-use?

  The device description does not specify whether the TS-1800 Medication Transfer Spike is designed for single-use or reuse. Users should refer to the manufacturer's instructions for proper handling and disposal guidelines.