---
kind: "section"
citation: "21 C.F.R. § 876.5210"
title: "21"
number: "876.5210"
heading: "Enema kit."
url: "https://uscodex.org/cfr/21/876.5210"
---

# §876.5210. Enema kit.

- (a) **Identification.** An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system ([§ 876.5220](/cfr/21/876.5220.md)).
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 876.9](/cfr/21/876.9.md). The device is exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000; 90 FR 55985, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000; 90 FR 55985, Dec. 4, 2025]