| Device Type ID | 2317 |
| Device Name | Separator, Automated, Blood Cell, Diagnostic |
| Regulation Description | Automated Blood Cell Separator. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9245 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GKT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2317 |
| Device | Separator, Automated, Blood Cell, Diagnostic |
| Product Code | GKT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Blood Cell Separator. |
| CFR Regulation Number | 864.9245 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FENWAL INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FRESENIUS | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
FRESENIUS KABI AG | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
FRESENIUS KABI USA LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HAEMONETICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
HAEMONETICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
TERUMO BCT | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 528 |
Device Operates Differently Than Expected | 125 |
Improper Or Incorrect Procedure Or Method | 71 |
Thermal Decomposition Of Device | 41 |
Insufficient Information | 33 |
Inadequate User Interface | 28 |
High Test Results | 23 |
Component Falling | 22 |
Use Of Device Problem | 20 |
Device Operational Issue | 14 |
Device Displays Incorrect Message | 13 |
Defective Component | 12 |
No Apparent Adverse Event | 11 |
Human-Device Interface Problem | 9 |
Mechanical Problem | 9 |
Air Leak | 9 |
Device Misassembled During Manufacturing / Shipping | 6 |
Filtration Problem | 6 |
Fluid Leak | 5 |
Nonstandard Device | 5 |
Device Slipped | 5 |
Clumping In Device Or Device Ingredient | 5 |
Occlusion Within Device | 5 |
Appropriate Term/Code Not Available | 4 |
Patient-Device Incompatibility | 4 |
Use Of Incorrect Control Settings | 4 |
Device Handling Problem | 3 |
Leak / Splash | 3 |
Needle | 3 |
Kinked | 3 |
Data Problem | 3 |
Contamination During Use | 2 |
Product Quality Problem | 2 |
Programming Issue | 2 |
Fire | 2 |
Sparking | 2 |
Smoking | 2 |
Unintended System Motion | 2 |
Misassembled | 2 |
Noise, Audible | 2 |
Shelf Life Exceeded | 2 |
Improper Flow Or Infusion | 2 |
Patient Device Interaction Problem | 2 |
Tube | 2 |
Clamp | 1 |
Complete Blockage | 1 |
Device Emits Odor | 1 |
Pumping Problem | 1 |
Device Maintenance Issue | 1 |
Decrease In Pressure | 1 |
Sticking | 1 |
Device Contamination With Biological Material | 1 |
Electrical Shorting | 1 |
Unintended Movement | 1 |
Incomplete Or Inadequate Connection | 1 |
Accessory Incompatible | 1 |
Partial Blockage | 1 |
Incorrect Or Inadequate Test Results | 1 |
Failure To Align | 1 |
Calibration Problem | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Charred | 1 |
Display Or Visual Feedback Problem | 1 |
Device Expiration Issue | 1 |
Loose Or Intermittent Connection | 1 |
Volume Accuracy Problem | 1 |
Insufficient Flow Or Under Infusion | 1 |
Device Alarm System | 1 |
Connection Problem | 1 |
Bags | 1 |
Backflow | 1 |
Circuit Failure | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Device Difficult To Setup Or Prepare | 1 |
Obstruction Of Flow | 1 |
Difficult To Open Or Close | 1 |
PC (Printed Circuit) Board | 1 |
Failure To Prime | 1 |
Failure To Sense | 1 |
Infusion Or Flow Problem | 1 |
Unexpected Therapeutic Results | 1 |
Material Discolored | 1 |
Improper Device Output | 1 |
Material Integrity Problem | 1 |
Alarm, Visual | 1 |
| Total Device Problems | 1099 |