510(k) · Cleared

Cleared

Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets

K012242510(k) SpecialCleared Aug 16, 200130-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

Fresenius Medical Care North America · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Cleared on Aug 16, 2001 as substantially equivalent to K971313 (National Medical Care, Inc., 1997) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Aug 16, 2001
Review: 30 days
Class: Class II
Product code: FJK
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K962081 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962081 Combilines Hemodialysis Blood Tubing SetNational Medical Care, Medical Products Div., Inc. · 1996 · Recalled
This deviceK012242 Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi…Fresenius Medical Care North America · 2001
Descendant · cites it directly · 0 of its ownK041042 Split Septum Injection SitesFresenius Medical Care North America · 2004

Most influential descendants

Showing 1 of 1 · See all

K041042Split Septum Injection SitesFresenius Medical Care North America · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962081	Combilines Hemodialysis Blood Tubing Set	National Medical Care, Medical Products Div., Inc.	1996	2
0 (this device)	K012242	Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets…	Fresenius Medical Care North America	2001	—
+1	K041042	Split Septum Injection Sites	Fresenius Medical Care North America	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K012242, 1996–2004Source: 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 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

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What was it cleared against? (3)

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
*	K971313	NMC Hemodialysis Arterial Blood Tubing Set Summary page 2 …predicate device for the Fresenius Single use Arterial Bloodline Sets with Alternate Pump Segment Material is: e Fresenius Hemodialysis Blood Tubing Sets cleared under K971313 (10/27/97) e Fresenius Combi Sets®cleared under #K962081 (11/01/96) and #K000451 (05/09/00). Fresenius Single Use Arterial Bloo…	National Medical Care, Inc.	1997	—
*	K962081	Combilines Hemodialysis Blood Tubing Set Summary page 2 …loodline Sets with Alternate Pump Segment Material is: e Fresenius Hemodialysis Blood Tubing Sets cleared under K971313 (10/27/97) e Fresenius Combi Sets®cleared under #K962081 (11/01/96) and #K000451 (05/09/00). Fresenius Single Use Arterial BloodLines with Alternate Pump Segment Material “Special 510(…	National Medical Care, Medical Products Div., Inc.	1996	2
*	K000451	Fresenius Combillines Single Needle Blood Tubing Set, Catalog #03-2290 Summary page 2 …nate Pump Segment Material is: e Fresenius Hemodialysis Blood Tubing Sets cleared under K971313 (10/27/97) e Fresenius Combi Sets®cleared under #K962081 (11/01/96) and #K000451 (05/09/00). Fresenius Single Use Arterial BloodLines with Alternate Pump Segment Material “Special 510(k)" Submission PAGE 12…	Fresenius Medical Care North America	2000	—

Also cleared against K971313: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041042	Split Septum Injection Sites	Fresenius Medical Care North America	2004	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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K041042 (Fresenius Medical Care North America, 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K971313.

How does its category compare?

All FJK devices

FJK 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

2007high 4 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJK

255in 2021

2007high 255 (2021) · low 116 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FJK

1in 2025

2007high 2 (2007) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FJK

1,487in 2025

2007high 1,487 (2025) · low 35 (2012)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 Fresenius Single use Arterial Bloodline Sets are intended for use as the extracorporeal blood circuit during hemodialysis. They are intended for single use only and are indicated for use with both conventional and high flux negative pressure

hemodialyzer equipment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012242 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012242: Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012242

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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