# K952631: Braun Hemodialysis Blood Circuits

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 30, 1996 after 327 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884243 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884243: Blood Tubing Set, Mediflex Intl. (1988) Summary page 1.

## Recalls of this device
- Dec 10, 2007 · Not classified · Z-1035-2008: Faulty tubing does not prime machine as intended.
- Dec 10, 2007 · Not classified · Z-1036-2008: Faulty tubing does not prime machine as intended.

## Indications for use
The configurations can be summarized tubing segments intended for use in transporting blood from a patient's vascular access device to hemodialyzer systems. Also, the tubing segments intended for use in transporting blood to a patient's vascular access device from such a system.

Source page: https://510kreport.com/device/K952631
Methodology: https://510kreport.com/methodology