FDA product code FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope
FCX is the FDA product code for insufflator, automatic carbon-dioxide for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 25 510(k) submissions under FCX, 3 in the last five years, from 19 different applicants. The average 510(k) review took 128 days (median 67); 123 days on average over the last three years. FDA has posted 2 recalls for FCX devices.
Classification
| Field | Value |
|---|---|
| Device name | Insufflator, Automatic Carbon-Dioxide For Endoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| 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 FCX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 67 |
| 2019 | 1 | 29 |
| 2020 | 1 | 60 |
| 2021 | 1 | 282 |
| 2023 | 1 | 30 |
| 2024 | 1 | 217 |
| 2026 | 1 | 29 |
Compare with all 510(k) review times · Search every FCX clearance
Top FCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E-Z-Em, Inc. | 4 | 2005-12-27 |
| Bracco Diagnostic, Inc. | 3 | 2014-02-14 |
| Palliare , Ltd. | 2 | 2023-03-24 |
| VISION MEDICAL Co., Ltd. | 1 | 2026-07-24 |
| Ide Vision, Ltd. | 1 | 2024-10-30 |
14 more applicants have FCX clearances. See the full list in Caduvo.
Most recent FCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262152 | VISION MEDICAL Co., Ltd. | VS-370CF, VS-370CT | 2026-07-24 | 29 |
| K240847 | Ide Vision, Ltd. | MedicCO2LON (MedicCO2LON) | 2024-10-30 | 217 |
| K230474 | Palliare , Ltd. | EVA5 Insufflator | 2023-03-24 | 30 |
| K202922 | Palliare , Ltd. | END 200 Endoscopic Tubeset | 2021-07-08 | 282 |
| K201096 | Karl Storz Endoscopy America, Inc. | CO2mbiLED | 2020-06-23 | 60 |
Recalls for FCX devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-01-15.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code FCX?
FCX is the FDA product code for insufflator, automatic carbon-dioxide for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FCX?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FCX?
Across 25 cleared submissions the average was 128 days from receipt to decision (median 67).
Which companies have the most FCX clearances?
E-Z-Em, Inc. (4); Bracco Diagnostic, Inc. (3); Palliare , Ltd. (2); VISION MEDICAL Co., Ltd. (1); Ide Vision, Ltd. (1).
Have FCX devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2021-01-15.
Next steps
- Run an FDA pathway report with predicate devices for product code FCX
- Run a recall and safety report across every FCX manufacturer
- Watch product code FCX 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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