# K063290: Gambro Quickset Bloodlines

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Jan 30, 2007 after 90 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“10810”).
- (no number) Gambro G Series Bloodline Sets for Hemodialysis: named in the summary without a submission number
- (no number) Cobe Hemaflo Blood Tubing Sets: named in the summary without a submission number

## Indications for use
The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

Source page: https://510kreport.com/device/K063290
Methodology: https://510kreport.com/methodology