510(k) · Cleared
Recalled · Class II · 2020Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products, Inc. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Nov 3, 2010 after a 264-day review. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“14143”). 1 later device descends from it. It has been recalled 5 times.
- Decided
- Nov 3, 2010
- Review
- 264 days
- Class
- Class II
- Product code
- FJK
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK100364 Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520Gambro Renal Products, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK123395 Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100364 | Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520 | Gambro Renal Products, Inc. | 2010 | — |
| +1 | K123395 | Nxstage System One Low Volume Cartridge Express | Nxstage Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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.
Planning a device in FJK? 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 |
|---|---|---|---|
| * | — | Gambro Cartridge® Blood Set Low Weight Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123395 | Nxstage System One Low Volume Cartridge Express | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 30, 2020 | Class II | Z-1123-2021 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123395 (Nxstage Medical, Inc., 2013) has gone furthest, with 0 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. 2010, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100364: Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100364
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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