510(k) · Cleared
ClearedBlood Tubing Sets (Sterile Fluid Path)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxstage Medical, Inc. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Feb 10, 2009 as substantially equivalent to K080807 (Nxstage Medical, Inc., 2008) after an 8-day review. Its family tree reaches back 2 generations to 1996. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 10, 2009
- Review
- 8 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953823 (1996). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK953823 Arterial Venous Blood Tubing SetMedisystems Corp. · 1996
- 1 generation backK080807 Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc. · 2008 · Recalled (Class I)
- This deviceK090255 Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc. · 2009
Class I recalls in this family
- K080807 Blood Tubing Sets (Sterile Fluid Path)direct predicate · 2008
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K080807 | Blood Tubing Sets (Sterile Fluid Path)Summary page 2…bing set is substantially equivalent to the following legally marketed predicate device, previously cleared by the FDA; Arterial-Venous Blood Tubing Sets, K080807, July 18, 2008 D. Device Description/Indications for Use: The blood tubing sets consist of a family of products which are used… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K080807Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K080807.
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. 2009, 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 blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090255: Blood Tubing Sets (Sterile Fluid Path).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090255
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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