Urine Meter, 250CC
FDA 510(k) K871042 · Salt Creek Medical Technologies
510(k) numberK871042
Submission
- Device name
- Urine Meter, 250CC
- Applicant
- Salt Creek Medical Technologies
Pinckney, MI, US - Received
- March 17, 1987
- Decision date
- March 25, 1987
- 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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| K110518 | IbagKNX · Traditional | Future Path Medical, LLC | 06/24/2011SE |
| K973364 | 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage BagKNX · Traditional | Maersk Medical A/S | 03/17/1998SE |
| K972887 | Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagKNX · Traditional | Medline Industries, Inc. | 12/11/1997SE |
| K971271 | Besecure External Urinary Collection SystemKNX · Traditional | Urology Research Intl., Inc. | 08/18/1997SE |
| 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 |
|---|---|---|
| K864683 | Neonatal Feeding KitKNT · Traditional | 04/17/1987SE |
| K871087 | S.C.M.T. PerforatorHGE · Traditional | 03/23/1987SE |
| K871075 | SCMT Umbilical ClampHFW · Traditional | 03/23/1987SE |
| K864296 | S.C.T. Multi Port, Injection SiteFPA · Traditional | 03/02/1987SE |
| K864682 | Salt Creek P.I. Tray · Traditional | 01/06/1987SE |
| K864692 | Extension SetsFPK · Traditional | 12/18/1986SE |
| K864693 | I.V. Start Kits · Traditional | 12/16/1986SE |
Questions and answers
When was Urine Meter, 250CC cleared by the FDA?
Urine Meter, 250CC (K871042) received a 510(k) decision of Substantially Equivalent on March 25, 1987, 8 days after the submission was received.
What is the product code of K871042?
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.