FDA product code FCD: Barium Enema Kit
FCD is the FDA product code for barium enema kit. It is a Class I device, regulated under 21 CFR 876.5210 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under FCD, from 2 different applicants. The average 510(k) review took 52 days (median 52).
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Barium Enema Kit |
| Device class | Class I |
| Regulation | 21 CFR 876.5210 |
| Review panel | RA — Radiology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCD clearance
Top FCD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lafayette Pharmaceuticals, Inc. | 1 | 1993-11-03 |
| Eisai U.S.A., Inc. | 1 | 1987-02-11 |
Most recent FCD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934585 | Lafayette Pharmaceuticals, Inc. | PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL | 1993-11-03 | 41 |
| K864835 | Eisai U.S.A., Inc. | TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* | 1987-02-11 | 64 |
Recalls for FCD devices
openFDA lists no recalls for product code FCD.
Frequently asked questions
What is FDA product code FCD?
FCD is the FDA product code for barium enema kit. It is a Class I device, regulated under 21 CFR 876.5210 and reviewed by the Radiology panel.
What device class is FCD?
Class I, regulation 21 CFR 876.5210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCD?
Across 2 cleared submissions the average was 52 days from receipt to decision (median 52).
Which companies have the most FCD clearances?
Lafayette Pharmaceuticals, Inc. (1); Eisai U.S.A., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FCD
- Run a recall and safety report across every FCD manufacturer
- Watch product code FCD 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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