510(k) · Cleared
Recalled · 2010Combilines Hemodialysis Blood Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Medical Care, Medical Products Div., Inc. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Nov 1, 1996 after a 157-day review. The FDA summary names no predicate by number. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 1, 1996
- Review
- 157 days
- Class
- Class II
- Product code
- FJK
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK962081 Combilines Hemodialysis Blood Tubing SetNational Medical Care, Medical Products Div., Inc. · 1996
- Descendant · cites it directly · 1 of its ownK012242 Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi…Fresenius Medical Care North America · 2001
- Descendant · cites it directly · 0 of its ownK041042 Split Septum Injection SitesFresenius Medical Care North America · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962081 | Combilines Hemodialysis Blood Tubing Set | National Medical Care, Medical Products Div., Inc. | 1996 | — |
| +1 | K012242 | Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets… | Fresenius Medical Care North America | 2001 | — |
| +1 | K041042 | Split Septum Injection Sites | Fresenius Medical Care North America | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2010 | Not classified | Z-0843-2011 | Device Design | Hemodialysis Blood tubing Sets may develop kinking of the arterial line. |
| Nov 19, 2010 | Not classified | Z-0844-2011 | Device Design | Hemodialysis Blood tubing Sets may develop kinking of the arterial line. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012242 (Fresenius Medical Care North America, 2001) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K962081 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962081: Combilines Hemodialysis Blood Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962081
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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