510(k) · Cleared
ClearedBlood Tubing Lines for Hemodialysis AV06C-E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nikkiso CO., LTD. · KOC Accessories, Blood Circuit, Hemodialysis
Cleared on Jul 28, 2023 as substantially equivalent to K082719 (Nikkiso CO., LTD., 2009) after a 57-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jul 28, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- KOC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010264 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK010264 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2001
- 1 generation backK082719 Nikkline Blood Tubing Lines with Transducer Protectors, Models…Nikkiso CO., LTD. · 2009
- This deviceK231589 Blood Tubing Lines for Hemodialysis AV06C-ENikkiso CO., LTD. · 2023
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 | K082719 | Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P… | Nikkiso CO., LTD. | 2009 | — |
| 0 (this device) | K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | Nikkiso CO., LTD. | 2023 | — |
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 KOC? 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 KOC device
- #1 K230514 Blood Tubing Lines for Hemodialysis AL Series…score 11.8 · 2 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 |
|---|---|---|---|
| * | K082719 | Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-PSummary page 5…Page 2/3 510(k) Summary (continued) Predicate Device 510(k) Number: K082719 Device Name: NIKKLINE BLOOD TUBING LINES WITH… | 2009 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K082719.
How does its category compare?
All KOC devicesKOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KOC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KOC
Too few KOC 510(k)s in any year since 2007 to give a median.
Recalls per year · KOC
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOC
50in 2025
MAUDE reports naming product code KOC, 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 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 2 | 12 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 1 | — | 1 | 165 |
| 2015 | 2 | — | 0 | 555 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 23 |
| 2018 | 0 | — | 3 | 37 |
| 2019 | 0 | — | 0 | 56 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 2 | — | 0 | 50 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use.
This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient’s blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231589: Blood Tubing Lines for Hemodialysis AV06C-E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231589
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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