510(k) · Decided
DecidedBioteque 3 in 1 Hemodialysis Blood Tubing Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioteque Corp. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Jul 9, 2002 as substantially equivalent to K972206 (Nipro Medical Corp., 1997) and 1 other predicate after a 246-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jul 9, 2002
- Review
- 246 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972206 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972206 Nipro Blood Tubing Set with Transducer and Solution Set for…Nipro Medical Corp. · 1997
- This deviceK013634 Bioteque 3 in 1 Hemodialysis Blood Tubing PackBioteque Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972206 | Nipro Blood Tubing Set with Transducer and Solution Set for Hemodialysis | Nipro Medical Corp. | 1997 | — |
| 0 (this device) | K013634 | Bioteque 3 in 1 Hemodialysis Blood Tubing Pack | Bioteque Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K972206 | Nipro Blood Tubing Set with Transducer and Solution Set for HemodialysisSummary page 1…assification: Class II . Predicate Device: Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K972206) & (K001465) 5. Device Description: The BIOTEQ@3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA BT-… | 1997 |
| * | K001465 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetSummary page 1…: Class II . Predicate Device: Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K972206) & (K001465) 5. Device Description: The BIOTEQ@3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA BT-… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
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 | — |
What is it indicated for?
The BIOTEQ* 3 in 1 Hemodialysis Blood Tubing Packs ( BT- 102DA BT- 102DB BT- 102DC BT- 102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterialhenous bloodline set, and any combination of two or three component of the following items: * An intravenous administration set for (use in administration…
Read the full statement (151 words)
The BIOTEQ* 3 in 1 Hemodialysis Blood Tubing Packs ( BT- 102DA BT- 102DB BT- 102DC BT- 102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterialhenous bloodline set, and any combination of two or three component of the following items:
* An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) ,
* AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , andor
* A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013634: Bioteque 3 in 1 Hemodialysis Blood Tubing Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013634
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026