21 CFR § 876.5830 - Hemodialyzer with disposable insert (Kiil type).

---
identifier: "/us/cfr/t21/s876.5830"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.5830 - Hemodialyzer with disposable insert (Kiil type)."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.5830"
section_name: "Hemodialyzer with disposable insert (Kiil type)."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY 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: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 876.5830 Hemodialyzer with disposable insert (Kiil type).

(a) *Identification.* A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that includes disposable inserts consisting of layers of semipermeable membranes which are sandwiched between support plates. The device is used with the extracorporeal blood system and the dialysate delivery system of the hemodialysis system and accessories (§ 876.5820).

(b) *Classification.* Class II (performance standards).

[48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]