Cobe Brat 2 Autologous Blood Salvage System With Crit-Line Hematocrit Sampling System

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

Full name

Cobe Brat 2 Autologous Blood Salvage System with the Crit-Line Hematocrit Sampling System Option

510(k) Number

K991986 ↗

FDA Product Code

CAC

Device Class

Class II

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Heat Exchanger Modification for Duo and Optima

  Class II

  FDA 510(k) K944267 Active Cleared 28 Apr 1995

• Cobe Patient Monitoring Products

  Class II

  FDA 510(k) K921343 Active Cleared 5 Jan 1993

• Cobe Sampling Site

  Class II

  FDA 510(k) K922484 Active Cleared 3 Dec 1992

• Cobe Cms-Fs Membrane Oxygenator

  Class II

  FDA 510(k) K926467 Active Cleared 9 Nov 1993

• Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator

  Class II

  FDA 510(k) K000255 Active Cleared 25 Apr 2000

• Standard Volume Processing Set for the Cobe Brat 2 Autologous Blood Salvage System

  Class II

  FDA 510(k) K973627 Active Cleared 3 Nov 1997

See all devices from Cobe Cardiovascular, Inc. →

• What is the Cobe Brat 2 Autologous Blood Salvage System used for?

  The Cobe Brat 2 is designed for autotransfusion, meaning it collects, anticoagulates, and filters blood lost during surgical procedures. This allows the reinfusion of salvaged red blood cells back into the patient, reducing the need for allogeneic blood transfusions. It is specifically intended for use in perioperative settings, particularly in anesthesiology, to improve patient blood management.

• Is the Cobe Brat 2 system reusable or single-use?

  The Cobe Brat 2 system itself is reusable, but it includes single-use disposable components. These disposable parts must be replaced after each procedure to ensure sterility and proper function, while the reusable components require adherence to strict sterile processing protocols.

• What does the Crit-Line Hematocrit Sampling System option provide?

  The optional Crit-Line Hematocrit Sampling System offers real-time, noninvasive measurement of the hematocrit (red blood cell concentration) in the reinfusion bag. This feature allows clinicians to monitor the quality of the salvaged blood product during processing, ensuring it meets safe reinfusion standards before administration to the patient.

• How is the Cobe Brat 2 system regulated?

  The Cobe Brat 2 Autologous Blood Salvage System is regulated under the FDA’s 510(k) clearance pathway, with clearance number K991986. It falls under device classification II (regulation number 868.5830) and is intended for use in perioperative autotransfusion procedures. The system requires proper training for operation to ensure safe and effective use.

• Are there any specific storage requirements for the disposable components?

  The disposable components of the Cobe Brat 2 system are single-use and must be stored according to the manufacturer’s instructions to maintain sterility and integrity. Proper storage conditions, such as temperature and humidity control, are critical to prevent contamination or degradation before use. Always refer to the included packaging guidelines for detailed storage recommendations.