FDA product code FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
FCM is the FDA product code for tray, catheterization, sterile urethral, with or without catheter (kit). It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 60 510(k) submissions under FCM, 3 in the last five years, from 33 different applicants. The average 510(k) review took 79 days (median 72); 118 days on average over the last three years. FDA has posted 43 recalls for FCM devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FCM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 224 |
| 2025 | 1 | 73 |
| 2026 | 1 | 162 |
Compare with all 510(k) review times · Search every FCM clearance
Top FCM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Latex Ind., Inc. | 8 | 1978-03-02 |
| Orion Life Systems, Inc. | 5 | 1990-07-20 |
| Concord Laboratories, Inc. | 5 | 1977-06-24 |
| Amsino International, Inc. | 3 | 2008-10-23 |
| Snyder Laboratories, Inc. | 3 | 1979-04-10 |
28 more applicants have FCM clearances. See the full list in Caduvo.
Most recent FCM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254076 | C.R. Bard, Inc. | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | 2026-05-29 | 162 |
| K250891 | Convatec Limited | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | 2025-06-06 | 73 |
| K223821 | Coloplast | Self-Cath Closed System | 2023-08-02 | 224 |
| K082831 | Amsino International, Inc. | AMSELF CLOSED CATHETERIZATION SYSTEM | 2008-10-23 | 27 |
| K070939 | Coloplast Manufacturing Us, LLC | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | 2007-06-01 | 58 |
Recalls for FCM devices
43 product recalls in 10 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2024-04-08.
| Year | Recalls |
|---|---|
| 2022 | 7 |
| 2023 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FCM?
FCM is the FDA product code for tray, catheterization, sterile urethral, with or without catheter (kit). It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is FCM?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code FCM?
Across 60 cleared submissions the average was 79 days from receipt to decision (median 72).
Which companies have the most FCM clearances?
Latex Ind., Inc. (8); Orion Life Systems, Inc. (5); Concord Laboratories, Inc. (5); Amsino International, Inc. (3); Snyder Laboratories, Inc. (3).
Have FCM devices been recalled?
Yes: 43 product recalls across 10 recall events; the most recent began 2024-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code FCM
- Run a recall and safety report across every FCM manufacturer
- Watch product code FCM 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times