Models DM-360 & DM-350-L Single Patient

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

510(k) Number

K792173 ↗

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 MODELS DM-360 & DM-350-L SINGLE PATIENT used for?

  This device is designed for the delivery of dialysate in a single-patient use configuration, as defined in the device data, and is intended for use in clinical settings to support dialysis treatment.

• How is the MODELS DM-360 & DM-350-L SINGLE PATIENT supplied and is it reusable?

  The device is supplied as a single-patient system, meaning it is intended for use on one patient only and is not designed for reuse; this configuration helps reduce cross-contamination risk in clinical environments.

• What regulatory clearance does the MODELS DM-360 & DM-350-L SINGLE PATIENT have?

  The device has received FDA 510(k) clearance under K-number K792173, which confirms it is substantially equivalent to a legally marketed predicate device, and is classified as a Class II device under regulation 876.5820.