Sr-Model 230 (Modification)

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

510(k) Number

K864106 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Surgical Instrument

  Class I

  FDA 510(k) K833541 Active Cleared 28 Nov 1983

• Syringe Pump

  Class II

  FDA 510(k) K822571 Active Cleared 8 Oct 1982

• Multiple Manual Surgical Instruments

  Class I

  FDA 510(k) K832686 Active Cleared 14 Oct 1983

• Sr- Model 230

  Class II

  FDA 510(k) K842289 Active Cleared 25 Jul 1984

• Non-Stetho 7, Um-15TP

  Class II

  FDA 510(k) K821989 Active Cleared 18 Oct 1982

• Gp-303

  Class II

  FDA 510(k) K831583 Active Cleared 19 Jul 1983

See all devices from Hirata Sangyo Co. USA, Inc. →

• What is the SR-MODEL 230 (MODIFICATION) infusion pump used for?

  The SR-MODEL 230 (MODIFICATION) is designed for the delivery of fluids in a controlled manner, as specified in its FDA 510(k) clearance. It is intended for use in general hospital settings where precise fluid administration is required, such as intravenous therapy or medication infusion, based on its classification under product code FRN and regulation number 880.5725.

• How was the SR-MODEL 230 (MODIFICATION) cleared for market release?

  The device was cleared through the FDA’s traditional 510(k) process under submission K864106, receiving a substantially equivalent decision on November 19, 1986. This means it was found to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed without requiring a premarket approval application.

• Is the SR-MODEL 230 (MODIFICATION) a single-use or reusable device?

  The provided device data does not specify whether the SR-MODEL 230 (MODIFICATION) is intended for single-use or reuse. Information regarding sterility, reusability, or reprocessing instructions is not included in the authorization or specification fields. Users should consult the manufacturer’s labeling for detailed guidance on intended use and handling.

• What regulatory classification applies to the SR-MODEL 230 (MODIFICATION)?

  The SR-MODEL 230 (MODIFICATION) is classified as a Class II medical device under FDA regulations, with product code FRN and regulation number 880.5725. This classification indicates it poses moderate risk and is subject to special controls to ensure safety and effectiveness, as determined by its 510(k) clearance.

• Who manufactures the SR-MODEL 230 (MODIFICATION) and where is it registered?

  The SR-MODEL 230 (MODIFICATION) is manufactured by Hirata Sangyo Co. USA, Inc., located at 810 S. Spring St., Suite 404, Los Angeles, CA 90014. The device’s establishment registration and device listing information are associated with this address, as reflected in the OpenFDA fields and registration number data provided in the device record.