510(k) · Cleared
ClearedDORA Tubing Sets for Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bain Medical Equipment (Guangzhou) Co., Ltd. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Cleared on Jun 16, 2017 as substantially equivalent to K072024 (Nipro Medical Corp., 2007) after a 373-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Jun 16, 2017
- Review
- 373 days
- Class
- Class II
- Product code
- FJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010264 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010264 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2001
- 1 generation backK072024 Nipro Blood Tubing Set with Transducer Protector and Priming Set…Nipro Medical Corp. · 2007 · Recalled
- This deviceK161582 DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK201866 NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK252423 NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251341 VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd. · 2026
- Descendant · cites it directly · 0 of its ownK202796 SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2021 · cites it directly2descendants
- K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2026 · 2 generations on0descendants
- K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd. · 2026 · 2 generations on0descendants
- K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming… | Nipro Medical Corp. | 2001 | — |
| −1 | K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model… | Nipro Medical Corp. | 2007 | 1 |
| 0 (this device) | K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017 | — |
| +1 | K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021 | — |
| +2 | K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2026 | — |
| +2 | K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | 2026 | — |
| +1 | K202796 | SANSIN Tubing Sets for Hemodialysis | Jiangxi Sanxin Medtec Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219…Summary page 5…n, it is subject to e-beam sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10 -6. 5. Identification of Predicate Device(s) K072024 Nipro® Set–Blood Tubing Set with Transducer Protector and Priming Set Nipro Medical Coporation 6. Non-Clinical Test… | 2007 |
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K201866 (Bain Medical Equipment (Guangzhou) Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K072024.
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. 2017, 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 DORA Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161582: DORA Tubing Sets for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161582
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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