Urinary Monitoring Sys 240
FDA 510(k) K840917 · Vital Metrics, Inc.
510(k) numberK840917
Submission
- Device name
- Urinary Monitoring Sys 240
- Applicant
- Vital Metrics, Inc.
Mchenry, IL, US - Received
- March 1, 1984
- Decision date
- May 1, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
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| K972887 | Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagKNX · Traditional | Medline Industries, Inc. | 12/11/1997SE |
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| K971929 | Amsino Urinary Leg BagKNX · Traditional | Amsino Intl., Inc. | 08/06/1997SE |
| K971764 | Welcon Hue-Vu Urinary Drainage BagKNX · Traditional | Welcon, Inc. | 07/29/1997SE |
| K964690 | Liberty ValveKNX · Traditional | Cleveland Medical Devices, Inc. | 03/21/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | Amsino Intl., Inc. | 03/18/1997SE |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | Customed, Inc. | 10/04/1996SE |
| K960949 | Prosys Bedside Drainage Bag (Sterile) Model 650167KNX · Traditional | Bristol-Myers Squibb | 04/19/1996SE |
More from Bristol-Myers Squibb
| 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 |
| K843441 | Urinary Drainage Container 2012-WITHFFG · Traditional | 01/03/1985SE |
| 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 Monitoring Sys 240 cleared by the FDA?
Urinary Monitoring Sys 240 (K840917) received a 510(k) decision of Substantially Equivalent on May 1, 1984, 61 days after the submission was received.
What is the product code of K840917?
The FDA product code is KNX – Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.