FDA product code FCE: Enema Kit
FCE is the FDA product code for enema kit. It is a Class I device, regulated under 21 CFR 876.5210 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 30 510(k) submissions under FCE, from 22 different applicants. The average 510(k) review took 79 days (median 63).
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 | Enema Kit |
| Device class | Class I |
| Regulation | 21 CFR 876.5210 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FCE clearance
Top FCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Plasco, Inc. | 3 | 1988-04-14 |
| The Healthcare Group Laboratories, Inc. | 3 | 1980-05-14 |
| Orion Life Systems, Inc. | 2 | 1990-06-28 |
| Custom Medical Products, Ltd. | 2 | 1990-04-13 |
| Clayton Medical Products, Inc. | 2 | 1983-12-27 |
17 more applicants have FCE clearances. See the full list in Caduvo.
Most recent FCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974042 | Amsino Intl., Inc. | AMSURE CLEANSING ENEMA SET | 1997-12-19 | 56 |
| K931896 | Lafayette Pharmacal, Inc. | PRO-FLO SYSTEM | 1993-08-26 | 133 |
| K922398 | Boston Pacific Medical, Inc. | 4 SURE TM ENEMA BAG SET | 1993-06-17 | 392 |
| K913620 | York County Blind Center | ENEMA KIT | 1991-11-01 | 80 |
| K904534 | R.A.C., Inc. | ENEMA BULB | 1990-12-21 | 78 |
Recalls for FCE devices
openFDA lists no recalls for product code FCE.
Frequently asked questions
What is FDA product code FCE?
FCE is the FDA product code for enema kit. It is a Class I device, regulated under 21 CFR 876.5210 and reviewed by the Gastroenterology and Urology panel.
What device class is FCE?
Class I, regulation 21 CFR 876.5210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCE?
Across 30 cleared submissions the average was 79 days from receipt to decision (median 63).
Which companies have the most FCE clearances?
Plasco, Inc. (3); The Healthcare Group Laboratories, Inc. (3); Orion Life Systems, Inc. (2); Custom Medical Products, Ltd. (2); Clayton Medical Products, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FCE
- Run a recall and safety report across every FCE manufacturer
- Watch product code FCE 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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