| Device Type ID | 2602 |
| Device Name | Pump, Infusion |
| Regulation Description | Infusion Pump. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FRN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2602 |
| Device | Pump, Infusion |
| Product Code | FRN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BAXTER HEALTHCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BAXTER HEALTHCARE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BELMONT INSTRUMENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAREFUSION 303, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARTICEPT MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONCERT MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOSPIRA, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOSPIRA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
IRADIMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PFIZER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
Q CORE MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZOLL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZYNO MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZYNO MEDICAL LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 8273 |
Excess Flow Or Over-Infusion | 3217 |
Break | 2633 |
Device Alarm System | 2468 |
Keypad | 2340 |
Device Operates Differently Than Expected | 1956 |
Insufficient Flow Or Under Infusion | 1741 |
False Alarm | 1712 |
Failure To Sense | 1633 |
Infusion Or Flow Problem | 1524 |
Device Inoperable | 1364 |
Alarm, Audible | 1338 |
Pump | 1039 |
Post | 1021 |
Fluid Leak | 951 |
Improper Flow Or Infusion | 895 |
Guide | 763 |
Adverse Event Without Identified Device Or Use Problem | 708 |
Battery Problem | 642 |
Overheating Of Device | 500 |
Reservoir | 472 |
Device Contamination With Chemical Or Other Material | 455 |
No Audible Alarm | 438 |
Output Problem | 430 |
Shielding Failure | 421 |
Shield | 420 |
Free Or Unrestricted Flow | 371 |
Pumping Stopped | 370 |
Inaccurate Flow Rate | 325 |
Obstruction Of Flow | 300 |
Material Rupture | 285 |
Leak / Splash | 283 |
Failure To Deliver | 281 |
Occlusion Within Device | 278 |
No Display / Image | 266 |
Inaccurate Delivery | 257 |
No Apparent Adverse Event | 255 |
Adapter (Adaptor) | 237 |
Appropriate Term/Code Not Available | 236 |
Alarm | 222 |
Mechanical Problem | 218 |
Defective Alarm | 214 |
Prong | 214 |
Volume Accuracy Problem | 200 |
Tube | 194 |
Disconnection | 174 |
Difficult Or Delayed Activation | 174 |
Battery | 164 |
Thermal Decomposition Of Device | 163 |
Failure To Power Up | 155 |
Power Cord | 154 |
Filling Problem | 153 |
Loss Of Power | 141 |
Crack | 139 |
Air Leak | 137 |
Protective Measures Problem | 133 |
Communication Or Transmission Problem | 125 |
Screen | 121 |
Housing | 119 |
No Flow | 116 |
Pin | 114 |
Cassette | 112 |
Use Of Device Problem | 108 |
Latch | 108 |
Motor | 104 |
Patient Device Interaction Problem | 101 |
Insufficient Information | 97 |
Failure To Infuse | 94 |
Filter | 90 |
Smoking | 87 |
Device Operational Issue | 87 |
Sparking | 86 |
Inadequate User Interface | 84 |
Electrical /Electronic Property Problem | 83 |
No Audible Prompt / Feedback | 82 |
Loose Or Intermittent Connection | 78 |
Nonstandard Device | 75 |
Device Component Or Accessory | 75 |
Power Problem | 75 |
Device Issue | 65 |
Clamp | 64 |
Cap | 64 |
Material Separation | 63 |
Sensor | 62 |
Scratched Material | 62 |
Bent | 61 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 60 |
Regulator | 59 |
Component Missing | 59 |
Sticking | 58 |
Material Integrity Problem | 57 |
Complete Loss Of Power | 56 |
Speaker | 55 |
Failure To Prime | 55 |
Device Sensing Problem | 53 |
Moisture Damage | 53 |
Pressure Problem | 52 |
Connection Problem | 52 |
Device Stops Intermittently | 51 |
Pumping Problem | 51 |
| Total Device Problems | 49480 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories | II | Jun-25-2015 |
| 2 | Baxter Healthcare Corp | II | Apr-16-2015 |
| 3 | Baxter Healthcare Corp. | II | Nov-29-2016 |
| 4 | Baxter Healthcare Corp. | II | Oct-01-2014 |
| 5 | Baxter Healthcare Corp. | I | Apr-25-2014 |
| 6 | Baxter Healthcare Corporation | II | Jun-07-2018 |
| 7 | Baxter Healthcare Corporation | II | May-04-2018 |
| 8 | Baxter Healthcare Corporation | II | Mar-12-2018 |
| 9 | Baxter Healthcare Corporation | II | Oct-02-2017 |
| 10 | Bayer Corp | II | May-30-2014 |
| 11 | Bayer Healthcare | II | Feb-08-2017 |
| 12 | Bayer Healthcare | II | Nov-11-2016 |
| 13 | Bayer Healthcare | II | Jan-11-2016 |
| 14 | CME America, LLC | II | Feb-19-2015 |
| 15 | CareFusion 303, Inc. | II | Jan-08-2018 |
| 16 | CareFusion 303, Inc. | II | Oct-19-2017 |
| 17 | CareFusion 303, Inc. | II | Jun-19-2017 |
| 18 | CareFusion 303, Inc. | II | Jun-19-2017 |
| 19 | CareFusion 303, Inc. | II | Mar-21-2017 |
| 20 | CareFusion 303, Inc. | I | Jan-18-2017 |
| 21 | CareFusion 303, Inc. | II | Sep-23-2016 |
| 22 | CareFusion 303, Inc. | II | Jun-28-2016 |
| 23 | CareFusion 303, Inc. | II | May-04-2016 |
| 24 | CareFusion 303, Inc. | I | Aug-14-2015 |
| 25 | CareFusion 303, Inc. | II | Jun-16-2015 |
| 26 | CareFusion 303, Inc. | II | Mar-23-2015 |
| 27 | CareFusion 303, Inc. | I | May-14-2014 |
| 28 | CareFusion Corporation | II | Jun-26-2015 |
| 29 | Elite Biomedical Solutions LLC | I | Aug-20-2015 |
| 30 | Fresenius Vial Sa | II | Nov-02-2018 |
| 31 | Hospira Inc. | II | Nov-04-2016 |
| 32 | Hospira Inc. | II | Nov-03-2016 |
| 33 | Hospira Inc. | II | Oct-24-2016 |
| 34 | Hospira Inc. | II | Sep-06-2016 |
| 35 | Hospira Inc. | II | Jul-08-2016 |
| 36 | Hospira Inc. | II | Jun-27-2016 |
| 37 | Hospira Inc. | II | Jun-03-2016 |
| 38 | Hospira Inc. | II | Feb-23-2016 |
| 39 | Hospira Inc. | I | Feb-23-2015 |
| 40 | Hospira Inc. | II | Feb-04-2015 |
| 41 | Hospira Inc. | II | Nov-24-2014 |
| 42 | Hospira Inc. | I | Oct-24-2014 |
| 43 | Hospira Inc. | II | Jul-10-2014 |
| 44 | Hospira Inc. | II | Jul-10-2014 |
| 45 | Hospira Inc. | II | Jun-03-2014 |
| 46 | Hospira Inc. | I | May-01-2014 |
| 47 | Hospira Inc. | I | May-01-2014 |
| 48 | Hospira Inc. | II | Apr-21-2014 |
| 49 | Hospira Inc., A Pfizer Company | II | Mar-24-2017 |
| 50 | Hospira Inc., A Pfizer Company | II | Sep-13-2016 |
| 51 | ICU | II | Jul-07-2017 |
| 52 | ICU Medical Inc | II | Dec-06-2017 |
| 53 | ICU Medical Inc | II | Nov-16-2017 |
| 54 | ICU Medical Inc | II | Aug-14-2017 |
| 55 | Intra Pump Infusion Systems | II | Oct-21-2014 |
| 56 | MOOG Medical Devices Group | II | Feb-11-2016 |
| 57 | Medtronic MiniMed Inc. | II | Jul-24-2015 |
| 58 | Medtronic MiniMed Inc. | II | Aug-08-2014 |
| 59 | Repro-Med Systems, Inc. | II | Jan-05-2018 |
| 60 | Smiths Medical ASD Inc. | II | Aug-08-2018 |
| 61 | Smiths Medical ASD Inc. | II | Mar-05-2018 |
| 62 | Smiths Medical ASD Inc. | II | Jan-04-2018 |
| 63 | Smiths Medical ASD Inc. | II | Jan-02-2018 |
| 64 | Smiths Medical ASD Inc. | II | Nov-01-2017 |
| 65 | Smiths Medical ASD Inc. | II | Aug-25-2017 |
| 66 | The Anspach Effort, Inc. | II | May-16-2014 |
| 67 | WalkMed Infusion, LLC | II | Jul-18-2016 |
| 68 | WalkMed Infusion, LLC | II | Nov-06-2015 |
| 69 | WalkMed Infusion, LLC | II | Mar-03-2014 |
| 70 | WalkMed, LLC | II | Nov-13-2017 |