# K070414: Gambro Cartridge Blood Sets

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Oct 12, 2007 after 242 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: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has 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) Cobe Cartridge Blood Tubing Set: named in the summary without a submission number

## Most influential descendants
- K201809: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (2021), 3 descendants of its own
- K232467: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (2023), 1 descendant of its own
- K250508: AK 98 Dialysis Machine (955607) (2025), 0 descendants of its own
- K211035: U9000 Plus Ultrafilter (2021), 0 descendants of its own

## Recalls of this device
- Apr 14, 2021 · Class II · Z-1684-2021: There is a potential leak between the venous patient connector and patient's hemodialysis access.
- Dec 30, 2020 · Class II · Z-1119-2021: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
- Dec 30, 2020 · Class II · Z-1122-2021: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
- Dec 30, 2020 · Class II · Z-1120-2021: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
- Dec 30, 2020 · Class II · Z-1121-2021: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
- Dec 30, 2020 · Class II · Z-1118-2021: 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.
- May 2, 2008 · Not classified · Z-1860-2008: Dialysis tubing sets may have occlusions restricting blood flow.
- May 2, 2008 · Not classified · Z-1861-2008: Dialysis tubing sets may have occlusions restricting blood flow.

## Indications for use
The Gambro Cartridge® Blood Set is intended for single use in a hemodialysis treatment using the Phoenix® and Centrysystem® 3 Dialysis Delivery Systems. The Low Weight model is used when a low extra-corporeal blood volume is recommended. The Low Weight model with a priming volume of 75 ml is indicated for patients with body weight greater than 20 Kg and lower or equal to 40 Kg. The standard models with a priming volume ranging from 103 ml to 162 ml are indicated for patients with body weight greater than 40 Kg.

Source page: https://510kreport.com/device/K070414
Methodology: https://510kreport.com/methodology