| Device Type ID | 5689 |
| Device Name | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Regulation Description | Powered Suction Pump. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4780 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 5689 |
| Device | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Product Code | JCX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Suction Pump. |
| CFR Regulation Number | 878.4780 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DING HWA CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DING HWA CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IMPACT INSTRUMENTATION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Emits Odor | 58 |
No Pressure | 47 |
Smoking | 43 |
Fluid Leak | 36 |
Device Operates Differently Than Expected | 31 |
Suction Problem | 30 |
Device Operational Issue | 29 |
Aspiration Issue | 29 |
Filtration Problem | 23 |
Sparking | 22 |
Device Handling Problem | 19 |
Failure To Pump | 18 |
Complete Blockage | 17 |
Pressure Problem | 16 |
Leak / Splash | 16 |
Electrical /Electronic Property Problem | 15 |
Failure To Power Up | 14 |
Pumping Problem | 11 |
Noise, Audible | 10 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 10 |
Misconnection | 10 |
Device Contamination With Body Fluid | 10 |
Overheating Of Device | 9 |
Device Damaged Prior To Use | 8 |
Incorrect Measurement | 8 |
Pumping Stopped | 6 |
Mechanical Problem | 6 |
Output Problem | 5 |
Unable To Obtain Readings | 5 |
Appropriate Term/Code Not Available | 5 |
Connection Problem | 4 |
Inappropriate Shock | 4 |
Improper Device Output | 4 |
Cut In Material | 4 |
Decrease In Suction | 3 |
Inaccurate Information | 3 |
Device Stops Intermittently | 3 |
Contamination During Use | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Material Frayed | 3 |
Use Of Device Problem | 3 |
Melted | 2 |
Occlusion Within Device | 2 |
Device Displays Incorrect Message | 2 |
Power Problem | 2 |
Fire | 2 |
Decrease In Pressure | 2 |
Electrical Shorting | 2 |
Device Alarm System | 2 |
Thermal Decomposition Of Device | 2 |
Break | 2 |
Improper Flow Or Infusion | 2 |
Temperature Problem | 1 |
Failure To Run On AC/DC | 1 |
Charred | 1 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
Failure To Shut Off | 1 |
No Audible Prompt / Feedback | 1 |
Failure To Zero | 1 |
Failure To Obtain Sample | 1 |
Detachment Of Device Component | 1 |
Air Leak | 1 |
Off-Label Use | 1 |
Excess Flow Or Over-Infusion | 1 |
Pre Or Post-Pumping Problem | 1 |
Failure To Sense | 1 |
Infusion Or Flow Problem | 1 |
Device Fell | 1 |
Suction Failure | 1 |
Material Integrity Problem | 1 |
Low Readings | 1 |
Battery Problem | 1 |
Device Inoperable | 1 |
Power Conditioning Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Backflow | 1 |
Bacterial Filter | 1 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
Increase In Suction | 1 |
| Total Device Problems | 654 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DeVilbiss Healthcare LLC | II | Jul-20-2016 |
| 2 | EMG Technology Co., Ltd. | II | Sep-13-2014 |
| 3 | Gardner Denver Thomas Inc | II | Jul-20-2015 |
| 4 | Laerdal Medical Corporation | II | Mar-12-2018 |
| 5 | Laerdal Medical Corporation | II | Apr-20-2017 |
| 6 | Stryker Instruments Div. Of Stryker Corporation | II | Aug-23-2016 |
| 7 | Stryker Instruments Div. Of Stryker Corporation | II | Jul-17-2015 |
| 8 | Stryker Instruments Div. Of Stryker Corporation | II | Jan-31-2014 |