U.S. Code of Federal Regulations
Regulations most recently checked for updates: Oct 07, 2025
(a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
(b) Classification. Class II (performance standards).