Dideco-Shiley Blood Separation Wash Bowl

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K872160 ↗

FDA Product Code

CAC

Device Class

Class II

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Shiley, Inc. →

• What is the primary purpose of the Dideco-Shiley Blood Separation Wash Bowl in surgical settings?

  The Dideco-Shiley Blood Separation Wash Bowl is designed specifically for intraoperative cell salvage systems. Its main function is to process blood components during autotransfusion procedures by separating and washing red blood cells to remove residual anticoagulants or contaminants, ensuring the collected blood is safe for reinfusion into the patient.

• Is the Dideco-Shiley Blood Separation Wash Bowl intended for reuse, or is it a single-use device?

  The Dideco-Shiley Blood Separation Wash Bowl is explicitly labeled as a single-use device. This means it is intended for one-time use in a surgical setting and should not be reused after processing a single patient’s blood.

• How is the device supplied, and what does this imply for handling?

  The device is supplied sterile and packaged individually, which means it comes pre-sterilized and sealed to maintain sterility until use. This ensures that when opened in the operating room, the device is ready for immediate use without additional sterilization steps, reducing the risk of contamination.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its classification?

  The Dideco-Shiley Blood Separation Wash Bowl received FDA clearance through a traditional 510(k) pathway, classified as a Class II device under the product code CAC (Apparatus, Autotransfusion). This classification indicates it is subject to general controls and special controls to ensure safety and effectiveness, but it does not require a third-party review panel for clearance.

• Can this device be used in conjunction with MRI equipment, or are there any restrictions?

  The device is explicitly not intended for MRI use, as stated in the regulatory data. This means it should not be placed in an MRI environment or used in procedures involving MRI imaging, as there may be compatibility risks or interference concerns.