AP900/PRP Module and Accessories, Modification

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

510(k) Number

K893218 ↗

FDA Product Code

CAC

Device Class

Class II

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Tcpm II Tourniquet Cuff Pressure Monitor

  Class I

  FDA 510(k) K900104 Active Cleared 15 Mar 1990

• Electromedics BT422-120 and BT422-40

  Class II

  FDA 510(k) K903392 Active Cleared 6 Sep 1990

• EL2-Series Blood Collection Reervoir

  Class II

  FDA 510(k) K930154 Active Cleared 1 Jul 1993

• Bt 794-Blood/Fluid Warmer

  Class II

  FDA 510(k) K822098 Active Cleared 20 Aug 1982

• Bt-795/P Automated Autotrans

  Class II

  FDA 510(k) K860306 Active Cleared 6 Mar 1986

• Dispos. Type T Thermocouple Temp.probe

  Class II

  FDA 510(k) K830592 Active Cleared 18 May 1983

See all devices from Electromedics, Inc. →

• What is the AP900/PRP Module designed for?

  The AP900/PRP Module is designed for intraoperative autotransfusion, which means it collects, filters, and reinfuses a patient’s own blood lost during surgery. This helps minimize the need for allogeneic (donor) blood transfusions and reduces exposure to donor-derived pathogens, particularly in critical surgeries like cardiac, orthopedic, or trauma procedures.

• Is the AP900/PRP Module single-use or reusable?

  The AP900/PRP Module is a reusable modular system. It is intended for use in controlled clinical environments like operating rooms, where it requires proper maintenance, cleaning, and sterilization between uses to ensure safe and effective operation.

• How is the AP900/PRP Module supplied, and what does it include?

  The AP900/PRP Module is supplied as a reusable system along with its associated accessories. The system is designed to integrate with surgical settings where blood salvage is critical, ensuring compatibility with intraoperative procedures. The exact accessories included may vary, but they are intended to support the collection, processing, and reinfusion of the patient’s blood.

• What type of sterility does the AP900/PRP Module require?

  The AP900/PRP Module operates under sterile conditions. Since it is a reusable device, it must be thoroughly cleaned and sterilized between uses to maintain sterility and prevent contamination. Proper sterilization protocols are essential to ensure the device remains safe for repeated use in clinical settings.

• What regulatory approval does the AP900/PRP Module hold?

  The AP900/PRP Module holds a 510(k) clearance from the FDA, specifically under the classification for Apparatus, Autotransfusion. The clearance number is K893218, and it is classified under FDA regulation 868.5830. This approval confirms that the device meets the necessary safety and effectiveness standards for its intended use.