510(k) Report

510(k) · Cleared

Cleared

Split Septum Injection Sites

K041042510(k) SpecialCleared Jul 16, 200485-day reviewClass II21 CFR 880.5440

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 · FPA Set, Administration, Intravascular

Cleared on Jul 16, 2004 as substantially equivalent to K962081 (National Medical Care, Medical Products Div., Inc., 1996) and 5 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1996.

Decided
Jul 16, 2004
Review
85 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K962081 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 2 other ancestors1997: 2 other ancestorsK962081 · Combilines Hemodialysis Blood Tubing Set · National Medical Care, Medical Products Div., Inc. · 1996 · recalledK012242 · Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets · Fresenius Medical Care North America · 2001199619982000200220042006
Other ancestors, by generation 1 generation back: 4 other ancestors K012242 · Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing Sets · Fresenius Medical Care North America · 2001K962081 · Combilines Hemodialysis Blood Tubing Set · National Medical Care, Medical Products Div., Inc. · 1996 · recalled0
  1. Root · 2 generations backK962081 Combilines Hemodialysis Blood Tubing SetNational Medical Care, Medical Products Div., Inc. · 1996 · Recalled
  2. 1 generation backK012242 Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi…Fresenius Medical Care North America · 2001
  3. This deviceK041042 Split Septum Injection SitesFresenius Medical Care North America · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K962081Combilines Hemodialysis Blood Tubing SetNational Medical Care, Medical Products Div., Inc.19962
−1K012242Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets…Fresenius Medical Care North America2001—
0 (this device)K041042Split Septum Injection SitesFresenius Medical Care North America2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720
200020
FIG. 1 — Lineage of K041042, 1996–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FPA? 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 FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K962081Combilines Hemodialysis Blood Tubing Set
Summary page 1
…ion Valve - Class II Device Product Code and Panel Code: KOC, 78 and FJK, 78 Predicate Device(s): * Fresenius CombiSets® Hemodialysis Blood Tubing Sets; K962081, SE 11/01/96 * Fresenius CombiSets® Hemodialysis Blood Tubing Sets; KOO1 107, SE 06/23/00 * Fresenius CombiSets…
National Medical Care, Medical Products Div., Inc.19962
*K001107Fresenius Combilines Low Volume Blood Tubing Set, Models 03-2291 (Post Pump) and 03-2292…Fresenius Medical Care North America2000—
*K000451Fresenius Combillines Single Needle Blood Tubing Set, Catalog #03-2290
Summary page 1
…962081, SE 11/01/96 * Fresenius CombiSets® Hemodialysis Blood Tubing Sets; KOO1 107, SE 06/23/00 * Fresenius CombiSets® Hemodialysis Blood Tubing Sets; K000451, SE 05/09/00 * Fresenius Arterial Blood Tubing Sets; K971313, SE 10/27/97 * Fresenius Venous Blood Tubing Sets;…
Fresenius Medical Care North America2000—
*K971313NMC Hemodialysis Arterial Blood Tubing Set
Summary page 1
…Tubing Sets; KOO1 107, SE 06/23/00 * Fresenius CombiSets® Hemodialysis Blood Tubing Sets; K000451, SE 05/09/00 * Fresenius Arterial Blood Tubing Sets; K971313, SE 10/27/97 * Fresenius Venous Blood Tubing Sets; K971687, SE 07/29/97 * Fresenius Single Use Arterial Bloodli…
National Medical Care, Inc.1997—
*K971687Hemodialysis Venous Blood Tubing Set or Similar Trade Name
Summary page 1
…Hemodialysis Blood Tubing Sets; K000451, SE 05/09/00 * Fresenius Arterial Blood Tubing Sets; K971313, SE 10/27/97 * Fresenius Venous Blood Tubing Sets; K971687, SE 07/29/97 * Fresenius Single Use Arterial Bloodline Sets with Alternate Pump Segment Material, K012242,…
National Medical Care, Inc.1997—
*K012242Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis…
Summary page 1
…0/27/97 * Fresenius Venous Blood Tubing Sets; K971687, SE 07/29/97 * Fresenius Single Use Arterial Bloodline Sets with Alternate Pump Segment Material, K012242, 08/16/01 Description: The Split Septum Injection Sites are designed for use during hemodialysis with eit…
Fresenius Medical Care North America2001—

Also cleared against K962081: 1 other device →

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 8 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 1 other device also cites its predicate K962081.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The Fresenius CombSets are intended for use as the extracorporeal blood circuit during Hemodialysis. They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment. The Fresenius Venous Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is indicated for use…

Read the full statement (117 words)

The Fresenius CombSets are intended for use as the extracorporeal blood circuit during Hemodialysis. They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

The Fresenius Venous Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

The Fresenius Arterial Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Arterial Bloodline is intended to for use with conventional and high flux negative pressure hemodialyzer equipment.

Indications for use as stated in the FDA summary.

Also cleared against K962081

1 other device cites the same predicate.

  • K012242Fresenius Arterial Bloodline Sets for Hemodialysis, Fresenius Combi Sets Hemodialysis Blood Tubing SetsFresenius Medical Care North America · 2001

More from Fresenius Medical Care North America

42 FDA decisions under this applicant name. See the company

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  • K152367Optiflux dialyzerFresenius Medical Care North America · 20151 recall
  • K123262Optiflux Ultra DialyzerFresenius Medical Care North America · 2014

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https://510kreport.com/device/K041042 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041042: Split Septum Injection Sites.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041042

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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