Vial Syringe Pumps, SE200, SE200B & SE400

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

510(k) Number

K852073 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Plume Y Set

  Class II

  FDA 510(k) K854951 Active Cleared 8 Jan 1986

• Vital Catheter

  Class II

  FDA 510(k) K791489 Active Cleared 26 Oct 1979

• Biospal (R) 1800S

  Class II

  FDA 510(k) K834589 Active Cleared 4 Feb 1984

• Plume Fistula Needle

  Class II

  FDA 510(k) K841791 Active Cleared 9 Jul 1984

• Mod. 300 Anesth. Vol. Ventilator W/Alarm

  Class II

  FDA 510(k) K800650 Active Cleared 2 Apr 1980

• Disscap Hollow Fiber Dialyzer

  Class II

  FDA 510(k) K802466 Active Cleared 12 Nov 1980

See all devices from Hospal Medical Corp. →

• What are the Vial Syringe Pumps SE200, SE200B & SE400 used for?

  These are infusion pumps designed for medical use in general hospital settings. They are classified as Pump, Infusion devices and are intended for various infusion applications within hospital environments.

• What regulatory approvals do the Vial Syringe Pumps have?

  The Vial Syringe Pumps have FDA 510(k) clearance with number K852073, issued on June 7, 1985. They are classified under regulation 880.5725 with product code FRN.

• Are the Vial Syringe Pumps single-use or reusable?

  The device data does not specify whether the Vial Syringe Pumps are single-use or reusable. No information regarding sterility or single-use status is provided in the available specifications.

• What models of Vial Syringe Pumps are available?

  The Vial Syringe Pumps are available in three models: SE200, SE200B, and SE400. These models are designed for similar purposes but may have different specifications or features not detailed in the provided data.