| Device Type ID | 1685 |
| Device Name | Urinometer, Mechanical |
| Regulation Description | Urine Flow Or Volume Measuring System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.1800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EXR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1685 |
| Device | Urinometer, Mechanical |
| Product Code | EXR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urine Flow Or Volume Measuring System. |
| CFR Regulation Number | 876.1800 [🔎] |
| Device Problems | |
|---|---|
Disconnection | 23 |
Occlusion Within Device | 18 |
No Flow | 7 |
Detachment Of Device Component | 7 |
Leak / Splash | 6 |
Defective Component | 5 |
Device Operates Differently Than Expected | 5 |
Infusion Or Flow Problem | 5 |
Decoupling | 3 |
Partial Blockage | 3 |
Restricted Flow Rate | 3 |
Unable To Obtain Readings | 3 |
Positioning Problem | 2 |
Break | 2 |
Mechanical Problem | 2 |
Connection Problem | 2 |
Delivered As Unsterile Product | 2 |
Loss Of Or Failure To Bond | 1 |
Component Missing | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Migration Or Expulsion Of Device | 1 |
Device Damaged Prior To Use | 1 |
Free Or Unrestricted Flow | 1 |
Positioning Failure | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 106 |