21 CFR § 864.9125 - Vacuum-assisted blood collection system.

---
identifier: "/us/cfr/t21/s864.9125"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.9125 - Vacuum-assisted blood collection system."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.9125"
section_name: "Vacuum-assisted blood collection system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY 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."
cfr_part: "864"
---


# 864.9125 Vacuum-assisted blood collection system.

(a) *Identification.* A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.

(b) *Classification.* Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]