21 CFR § 868.5760 - Cuff spreader.

---
identifier: "/us/cfr/t21/s868.5760"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 868.5760 - Cuff spreader."
title_number: 21
title_name: "Food and Drugs"
section_number: "868.5760"
section_name: "Cuff spreader."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "868"
part_name: "ANESTHESIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 31142, July 16, 1982, unless otherwise noted."
cfr_part: "868"
---


# 868.5760 Cuff spreader.

(a) *Identification.* A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001; 90 FR 55983, Dec. 4, 2025]