Urinary Drainage Container 2012-WITH
FDA 510(k) K843441 · Vital Metrics, Inc.
510(k) numberK843441
Submission
- Device name
- Urinary Drainage Container 2012-WITH
- Applicant
- Vital Metrics, Inc.
San Diego, CA, US - Received
- September 4, 1984
- Decision date
- January 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893827 | Peak Flow Rate MeterFFG · Traditional | Laytech Medical Co. | 08/11/1989SE |
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | Medical Engineering Corp. | 02/08/1989SE |
| K850169 | Eris Uro-Diagnostic SystemFFG · Traditional | Eris Medical Technology | 04/22/1985SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | Epcom Medical Systems, Inc. | 02/25/1985SE |
| K843442 | Urinary Drainage Container 2013 withFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K844030 | Accumeter Electronic Urinemeter SystemFFG · Traditional | Travenol Laboratories, S.A. | 11/20/1984SE |
| K843224 | Uropump Model 1711FFG · Traditional | Life-Tech Intl., Inc. | 10/19/1984SE |
| K833043 | UrometerFFG · Traditional | Browne Medical, Inc. | 02/04/1984SE |
| K813641 | Vital Metrics Urine Monitoring SystemFFG · Traditional | Vital Metrics, Inc. | 03/01/1982SE |
| K813082 | Ureofix 500 Urine Measuring SystemFFG · Traditional | Burron Medical Products, Inc. | 12/31/1981SE |
More from Burron Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883201 | Vital-Vue Illumination, Suction & Irrigation SysHBI · Traditional | 09/26/1988SE |
| K882956 | Vital-Vue Illumination, Suction and IrrigationHBI · Traditional | 08/03/1988SE |
| K844973 | Irriga Suc Illum Isis 710 & 7100 Series · Traditional | 03/18/1985SE |
| K843442 | Urinary Drainage Container 2013 withFFG · Traditional | 01/03/1985SE |
| K840917 | Urinary Monitoring Sys 240KNX · Traditional | 05/01/1984SE |
| K834448 | Urinary Drainage ContainerKNX · Traditional | 02/10/1984SE |
| K832526 | Urotrack PlusKNX · Traditional | 09/19/1983SE |
| K813641 | Vital Metrics Urine Monitoring SystemFFG · Traditional | 03/01/1982SE |
Questions and answers
When was Urinary Drainage Container 2012-WITH cleared by the FDA?
Urinary Drainage Container 2012-WITH (K843441) received a 510(k) decision of Substantially Equivalent on January 3, 1985, 121 days after the submission was received.
What is the product code of K843441?
The FDA product code is FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.1800.