Ucd Urine Specimen Collector
FDA 510(k) K854173 · Baker Instructions Corp.
510(k) numberK854173
Submission
- Device name
- Ucd Urine Specimen Collector
- Applicant
- Baker Instructions Corp.
Allentown, PA, US - Received
- October 15, 1985
- Decision date
- November 4, 1985
- 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
Other 510(k)s with product code KNX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K882612 | System 9000 Diff Model Automated Cell CounterGKZ · Traditional | 09/07/1988SE |
| K873596 | Baker TDM Theophylline AssayKLS · Traditional | 10/20/1987SE |
| K870603 | System 9000 Automated Cell CounterGKL · Traditional | 03/31/1987SE |
| K850386 | System 8000 Cell CounterGKL · Traditional | 05/02/1985SE |
| K833116 | Spirit Chemistry SystemJJE · Traditional | 11/07/1983SE |
| K832716 | Encore Chemistry AnalyzerJJG · Traditional | 10/04/1983SE |
| K830641 | Encore Chemistry AnalyzerJJG · Traditional | 04/05/1983SE |
| K821956 | Haem-C Plus Blood Reference ControlsJCN · Traditional | 07/30/1982SE |
| K811694 | Centrifichem Alt/Agpt Optimized ReagentCKA · Traditional | 07/01/1981SE |
Questions and answers
When was Ucd Urine Specimen Collector cleared by the FDA?
Ucd Urine Specimen Collector (K854173) received a 510(k) decision of Substantially Equivalent on November 4, 1985, 20 days after the submission was received.
What is the product code of K854173?
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.