FDA product code FCN: Urinary Drainage Collection Kit, For Indwelling Catheter
FCN is the FDA product code for urinary drainage collection kit, for indwelling catheter. It is a Class II device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under FCN, from 9 different applicants. The average 510(k) review took 166 days (median 82). FDA has posted 3 recalls for FCN devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Device class | Class II |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCN clearance
Top FCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Inventors Corp., Inc. | 2 | 1994-09-07 |
| Trinity Laboratories, Inc. | 1 | 1995-06-15 |
| Catco Medical, Inc. | 1 | 1995-02-16 |
| Mentor Corp. | 1 | 1992-08-14 |
| Knight Medical, Inc. | 1 | 1988-12-19 |
4 more applicants have FCN clearances. See the full list in Caduvo.
Most recent FCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951443 | Trinity Laboratories, Inc. | STANDARD FOLEY SYSTEM PAK | 1995-06-15 | 78 |
| K945258 | Catco Medical, Inc. | CATCO URINARY COLLECTION KIT | 1995-02-16 | 111 |
| K915166 | Medical Inventors Corp., Inc. | MICROCYCLER | 1994-09-07 | 1027 |
| K922346 | Mentor Corp. | FEMALE URINE SAMPLING DEVICE | 1992-08-14 | 87 |
| K890096 | Medical Inventors Corp., Inc. | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG | 1989-07-14 | 185 |
Recalls for FCN devices
3 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-12-04.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code FCN?
FCN is the FDA product code for urinary drainage collection kit, for indwelling catheter. It is a Class II device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is FCN?
Class II, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCN?
Across 10 cleared submissions the average was 166 days from receipt to decision (median 82).
Which companies have the most FCN clearances?
Medical Inventors Corp., Inc. (2); Trinity Laboratories, Inc. (1); Catco Medical, Inc. (1); Mentor Corp. (1); Knight Medical, Inc. (1).
Have FCN devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2023-12-04.
Next steps
- Run an FDA pathway report with predicate devices for product code FCN
- Run a recall and safety report across every FCN manufacturer
- Watch product code FCN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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