Single Patient Systems

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

510(k) Number

K780682 ↗

FDA Product Code

FKP

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Male Luer Connector & Hinged Cap

  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

  Class II

  FDA 510(k) K791044 Active Cleared 13 Jun 1979

• Ultrafiltration Controller

  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 Single Patient Systems device used for?

  The Single Patient Systems device is a dialysate delivery system intended for single patient use in gastroenterology and urology settings, as indicated by the advisory committee review during its FDA 510(k) submission.

• Is the Single Patient Systems device intended for single use or reuse?

  The device is designed for single patient use, meaning it is intended to be used on one patient only and not reused, as explicitly stated in its description and classification as a single patient system.

• How was the Single Patient Systems device cleared for market?

  The device received FDA 510(k) clearance through a traditional submission process, identified by K780682, and was found substantially equivalent to a predicate device, leading to its clearance on June 22, 1978.