510(k) · Cleared

Cleared

Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P

K082719510(k) TraditionalCleared Mar 30, 2009194-day reviewClass II21 CFR 876.5820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nikkiso CO., LTD. · KOC Accessories, Blood Circuit, Hemodialysis

Cleared on Mar 30, 2009 as substantially equivalent to K010264 (Nipro Medical Corp., 2001) after a 194-day review. Its family tree reaches back 1 generation to 2001. 13 later devices descend from it.

Decided: Mar 30, 2009
Review: 194 days
Class: Class II
Product code: KOC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010264 (2001). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK010264 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2001
This deviceK082719 Nikkline Blood Tubing Lines with Transducer Protectors, Models…Nikkiso CO., LTD. · 2009
Descendant · cites it directly · 8 of its ownK120823 BVM Hemodialysis Blood Tubing Set with Attached Priming Set and…Fresenius Medical Care North America, Design Cente · 2012
Descendant · 2 generations on · 7 of its ownK140841 Tablo CartridgeHome Dialysis Plus · 2014
Descendant · 3 generations on · 3 of its ownK193670 SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd. · 2020
Descendant · cites it directly · 2 of its ownK230514 Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood…Nikkiso CO., LTD. · 2023
Descendant · 4 generations on · 2 of its ownK210661 SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd. · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2012high 2 (2021) · low 0 (2013)2026

Most influential descendants

Showing 5 of 13 · See all

K120823BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsFresenius Medical Care North America, Design Cente · 2012 · cites it directly8descendants
K140841Tablo CartridgeHome Dialysis Plus · 2014 · 2 generations on7descendants
K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd. · 2020 · 3 generations on3descendants
K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…Nikkiso CO., LTD. · 2023 · cites it directly2descendants
K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd. · 2021 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010264	Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming…	Nipro Medical Corp.	2001	—
0 (this device)	K082719	Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P…	Nikkiso CO., LTD.	2009	—
+1	K120823	BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer…	Fresenius Medical Care North America, Design Cente	2012	—
+2	K140841	Tablo Cartridge	Home Dialysis Plus	2014	—
+3	K193670	SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set	Quanta Dialysis Technologies, Ltd.	2020	—
+1	K230514	Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines…	Nikkiso CO., LTD.	2023	—
+4	K210661	SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset	Quanta Dialysis Technologies, Ltd.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2019	1	0
2020	1	0
2021	2	0
2022	1	0
2023	2	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K082719, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K010264	Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set Summary page 1 …and accessories e. Predicate devices The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS is substantially equivalent to: 510(k): K010264 Trade name: Nipro® Blood Tubing Set with Transducer Protectors and Priming Set…	Nipro Medical Corp.	2001	—
†	K000702	Borla Transducer Protector & Haemotronic Transducer Protector	Fresenius Medical Care North America	2000	—

Also cleared against K010264: 1 other device →

What descends from it? (13)

See all 13

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120823	BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors	Fresenius Medical Care North America, Design Cente	2012	8
K230514	Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…	Nikkiso CO., LTD.	2023	2
K231589	Blood Tubing Lines for Hemodialysis AV06C-E	Nikkiso CO., LTD.	2023	0

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?

Its one ancestor has no recall.
Of its descendants, K120823 (Fresenius Medical Care North America, Design Cente, 2012) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K010264.

How does its category compare?

All KOC devices

KOC Accessories, Blood Circuit, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KOC

2in 2025

2007high 2 (2008) · low 0 (2010)2026

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

2007high 4 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KOC

50in 2025

2007high 555 (2015) · low 2 (2012)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?

The NIKKLINE BLOOD, TUBING LINES WITH TRANSDUCER PROTECTORS are disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician or other licensed practitioner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082719: Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082719

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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