510(k) · Cleared
Recalled · Class II · 2021Gambro Cartridge Blood Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Oct 12, 2007 after a 242-day review. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“10810”). 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 12 times.
- Decided
- Oct 12, 2007
- Review
- 242 days
- Class
- Class II
- Product code
- FJK
- Recalls
- 12
- Predicates
- 0
4 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK070414 Gambro Cartridge Blood SetsGambro Renal Products · 2007
- Descendant · cites it directly · 3 of its ownK201809 AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber…Baxter Healthcare Corportation · 2021
- Descendant · 2 generations on · 1 of its ownK232467 CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK250508 AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK211035 U9000 Plus UltrafilterBaxter Healthcare Corporation · 2021
Class I recalls in this family
- K232467 CleanCart A, CleanCart C, AK 98 Hemodialysis…2 generations on · 2023
Most influential descendants
Showing 4 of 4 · See all- K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryBaxter Healthcare Corportation · 2021 · cites it directly3descendants
- K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · 2 generations on1descendant
- K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025 · 3 generations on0descendants
- K211035U9000 Plus UltrafilterBaxter Healthcare Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070414 | Gambro Cartridge Blood Sets | Gambro Renal Products | 2007 | — |
| +1 | K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory | Baxter Healthcare Corportation | 2021 | — |
| +2 | K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | 2023 | Class I |
| +3 | K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | 2025 | — |
| +2 | K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 1 | 1 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FJK device
- #1 K252423 NovaLine Tubing Set for Hemodialysis (BL 124)score 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Cobe Cartridge Blood Tubing Set Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory | 2021 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2021 | Class II | Z-1684-2021 | Under Investigation by firm | There is a potential leak between the venous patient connector and patient's hemodialysis access. |
| Dec 30, 2020 | Class II | Z-1119-2021 | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| Dec 30, 2020 | Class II | Z-1122-2021 | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| Dec 30, 2020 | Class II | Z-1120-2021 | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| Dec 30, 2020 | Class II | Z-1121-2021 | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| Dec 30, 2020 | Class II | Z-1118-2021 | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| Apr 17, 2020 | Class II | Z-2195-2020 | Process control | Potential disconnection of tubing set. |
| Apr 17, 2020 | Class II | Z-2194-2020 | Process control | Potential disconnection of tubing set. |
| Apr 17, 2020 | Class II | Z-2193-2020 | Process control | Potential disconnection of tubing set. |
| Apr 17, 2020 | Class II | Z-2196-2020 | Process control | Potential disconnection of tubing set. |
| May 2, 2008 | Not classified | Z-1860-2008 | Process control | Dialysis tubing sets may have occlusions restricting blood flow. |
| May 2, 2008 | Not classified | Z-1861-2008 | Process control | Dialysis tubing sets may have occlusions restricting blood flow. |
The 5 latest of 12 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K201809 (Baxter Healthcare Corportation, 2021) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FJK devicesFJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FJK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FJK
255in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FJK
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FJK
1,487in 2025
MAUDE reports naming product code FJK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 116 | 2 | 135 |
| 2008 | 1 | — | 2 | 86 |
| 2009 | 1 | — | 0 | 76 |
| 2010 | 1 | — | 2 | 130 |
| 2011 | 0 | — | 0 | 243 |
| 2012 | 2 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 114 |
| 2014 | 1 | — | 0 | 116 |
| 2015 | 0 | — | 1 | 126 |
| 2016 | 1 | — | 0 | 139 |
| 2017 | 1 | — | 0 | 131 |
| 2018 | 1 | — | 0 | 119 |
| 2019 | 0 | — | 0 | 185 |
| 2020 | 0 | — | 1 | 190 |
| 2021 | 3 | 255 | 0 | 188 |
| 2022 | 0 | — | 0 | 362 |
| 2023 | 1 | — | 0 | 585 |
| 2024 | 1 | — | 0 | 417 |
| 2025 | 1 | — | 1 (1) | 1,487 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070414: Gambro Cartridge Blood Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070414
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026