FCN
10 FDA 510(k) clearances · Product code
87 daysmedian time to decision
1027 days90th percentile
10clearances measured
FDA profile
- Official device name
- Urinary Drainage Collection Kit, For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1997: 4 · 1998: 10 · 1999: 4 · 2003: 1 · 2004: 5 · 2014: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STANDARD FOLEY SYSTEM PAK (K951443) | Trinity Laboratories, Inc. | 1995-06-15 |
| CATCO URINARY COLLECTION KIT (K945258) | Catco Medical, Inc. | 1995-02-16 |
| MICROCYCLER (K915166) | Medical Inventors Corp., Inc. | 1994-09-07 |
| FEMALE URINE SAMPLING DEVICE (K922346) | Mentor Corp. | 1992-08-14 |
| BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (K890096) | Medical Inventors Corp., Inc. | 1989-07-14 |
| DOUBLE CLOSED URINARY DRAINAGE SYSTEM (K883886) | Knight Medical, Inc. | 1988-12-19 |
| LAKE FOLEY CATHETERIZATION TRAY (K883610) | Lake Medical Products, Inc. | 1988-10-12 |
| URINARY DRAINAGE MONITORING SYSTEM (K780134) | Medical Devices, Inc. | 1978-02-02 |
| URINE SPECIMEN COLLECTING DEVICE (K772133) | Kendall Research Center | 1977-11-28 |
| UROGARD URINARY DRAINAGE BAG (K771210) | Terumo America, Inc. | 1977-07-11 |
Track FCN automatically
Every clearance here is in the API, with alerts when new ones post.