# K100364: Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: Nov 3, 2010 after 264 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 (“14143”).
- (no number) Gambro Cartridge® Blood Set Low Weight: named in the summary without a submission number

## Most influential descendants
- K123395: Nxstage System One Low Volume Cartridge Express (2013), 0 descendants of its own

## Recalls of this device
- Dec 30, 2020 · Class II · Z-1123-2021: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
- Apr 17, 2020 · Class II · Z-2195-2020: Potential disconnection of tubing set.
- Apr 17, 2020 · Class II · Z-2194-2020: Potential disconnection of tubing set.
- Apr 17, 2020 · Class II · Z-2193-2020: Potential disconnection of tubing set.
- Apr 17, 2020 · Class II · Z-2196-2020: Potential disconnection of tubing set.

## Indications for use
The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System. The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

Source page: https://510kreport.com/device/K100364
Methodology: https://510kreport.com/methodology