Sps-Single Patient System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K821139 ↗

FDA Product Code

FIR

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K820169 Active Cleared 5 Feb 1982

• Parallel Plate Dialyzer Holder

  Class II

  FDA 510(k) K811292 Active Cleared 2 Jun 1981

• Tracheostomy Tubes, Short and Long Term

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  FDA 510(k) K791044 Active Cleared 13 Jun 1979

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  Class II

  FDA 510(k) K832547 Active Cleared 3 Jan 1984

• Extracorporeals' Alternate Membrane

  Class II

  FDA 510(k) K801344 Active Cleared 21 Jul 1980

• Intersept* Venous Reservoir Bag & Holder

  Class II

  FDA 510(k) K803059 Active Cleared 22 Dec 1980

See all devices from Extracorporeal Medical Specialities, Inc. →

• What is the primary clinical use of the SPS-Single Patient System?

  The SPS-Single Patient System is designed to function as an extra-luminal blood pump within a hemodialysis system. It is indicated for the treatment of patients suffering from renal failure or specific toxemic conditions.

• What is the regulatory classification of this blood pump?

  This device is classified as a class 2 medical device under regulation number 876.5820. It has received FDA 510(k) clearance under the submission number K821139, confirming it is substantially equivalent to other legally marketed devices.

• Who is the manufacturer of the SPS-Single Patient System?

  The device is manufactured by Extracorporeal Medical Specialities, Inc., located in King of Prussia, Pennsylvania. They are the official applicant responsible for the device's regulatory filing and specifications.