StacksVerified U.S. regulatory reference

21 CFR §868.5830

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
  2. (b)Classification. Class II (performance standards).