510(k) Report

510(k) · Cleared

Cleared

Maxzero Extension Set with Needless Connector

K140831510(k) TraditionalCleared Apr 15, 201413-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

Care Fusion · FPA Set, Administration, Intravascular

Cleared on Apr 15, 2014 as substantially equivalent to K132413 (Care Fusion, 2013) and 2 other predicates after a 13-day review. Its family tree reaches back 6 generations to 1995. 13 later devices descend from it.

Decided
Apr 15, 2014
Review
13 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K942988 (1995). 16 ancestors in all. 13 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2005: 1 other ancestor2012: 1 other ancestor2007: 1 other ancestor1999: 2 other ancestors2009: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor2003: 1 other ancestor2020: 2 descendants cleared2017: 3 descendants cleared2016: 1 descendant cleared2023: 2 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant clearedK942988 · Filtered Extension Sets · B. Braun of America, Inc. · 1995 · recalledK955585 · V2 Injection Site · B.Braun Medical, Inc. · 1996 · recalledK973167 · Positive Pressure Connector · Icu Medical, Inc. · 1997K021692 · CLC2000 Catheter Patency Device · Icu Medical, Inc. · 2003K100434 · Clave Neutron · Icu Medical, Inc. · 2010 · recalledK132413 · MZ1000 · Care Fusion · 20131995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 4 other ancestors4 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K132413 · MZ1000 · Care Fusion · 2013K100434 · Clave Neutron · Icu Medical, Inc. · 2010 · recalledK021692 · CLC2000 Catheter Patency Device · Icu Medical, Inc. · 2003K973167 · Positive Pressure Connector · Icu Medical, Inc. · 1997K955585 · V2 Injection Site · B.Braun Medical, Inc. · 1996 · recalledK942988 · Filtered Extension Sets · B. Braun of America, Inc. · 1995 · recalled−50
  1. Root · 6 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
  2. 5 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
  3. 4 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
  4. 3 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
  5. 2 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
  6. 1 generation backK132413 MZ1000Care Fusion · 2013
  7. This deviceK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
  8. Descendant · cites it directly · 4 of its ownK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
  9. Descendant · 2 generations on · 3 of its ownK182897 Velano Vascular Q2 Extension SetVelano Vascular · 2019
  10. Descendant · cites it directly · 3 of its ownK153293 Extension SetB.Braun Medical, Inc. · 2016 · Recalled
  11. Descendant · 3 generations on · 2 of its ownK200439 Velano ExT Extension SetVelano Vascular · 2021
  12. Descendant · 4 generations on · 0 of its ownK251257 nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with…Np Medical · 2025

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2016: 12017: 32019: 12020: 22021: 22022: 12023: 22025: 1
2016high 3 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 13 · See all
  • K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017 · cites it directly4descendants
  • K182897Velano Vascular Q2 Extension SetVelano Vascular · 2019 · 2 generations on3descendants
  • K153293Extension SetB.Braun Medical, Inc. · 2016 · cites it directly3descendants
  • K200439Velano ExT Extension SetVelano Vascular · 2021 · 3 generations on2descendants
  • K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…Np Medical · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K942988Filtered Extension SetsB. Braun of America, Inc.199532
−5K955585V2 Injection SiteB.Braun Medical, Inc.199627
−4K973167Positive Pressure ConnectorIcu Medical, Inc.1997—
−3K021692CLC2000 Catheter Patency DeviceIcu Medical, Inc.2003—
−2K100434Clave NeutronIcu Medical, Inc.20103
−1K132413MZ1000Care Fusion2013—
0 (this device)K140831Maxzero Extension Set with Needless ConnectorCare Fusion2014—
+1K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc.2017—
+2K182897Velano Vascular Q2 Extension SetVelano Vascular2019—
+1K153293Extension SetB.Braun Medical, Inc.20168
+3K200439Velano ExT Extension SetVelano Vascular2021—
+4K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle…Np Medical2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199920
200010
200310
200510
200710
200810
200910
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201730
201910
202020
202120
202210
202320
202510
FIG. 1 — Lineage of K140831, 1995–2025Source: 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
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K132413MZ1000
Summary page 1
…Manufacturer 510(k) # Date Cleared MZ1000 Needleless Connector CareFusion K132413 August 29, 2013 Medegen Pressure Rated CareFusion (formerly K083472 Decemb…
Care Fusion2013—
*K083472Medegen Pressure Rated Extension Sets
Summary page 1
…or CareFusion K132413 August 29, 2013 Medegen Pressure Rated CareFusion (formerly K083472 December 9, 2008 Extension Sets Medlegen) _______________ Medle…
Medegen, Inc.20082
*K051499Intravascular Administration Set and Extension Set
Summary page 1
…Sets Medlegen) _______________ Medlegen Intravascular CareFusion (formerly K051499 June 22, 2005 Administration Set and Medegen) Extension Set _ _ _ _ _ _ _…
Medegen Medical Manufacturing Services200524

Also cleared against K132413: 5 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc.20174
K153293Extension SetB.Braun Medical, Inc.20163
K222780LILY Extension Tube and Needleless ConnectorLily Medical Corporation20230
K193088MaxZero Extension Sets with Needle-Free Connector (s)Carefusion, Inc.20200
K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector (s)Cair Lgl20170
K171957MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc.20170

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 19 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
  • 10 of the 16 ancestors have a recall of any class.
  • Of its descendants, K162804 (Quest Medical, Inc., 2017) has gone furthest, with 4 descendants of its own.
  • 5 other devices also cite its predicate K132413.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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?

Pressure Rated: The MaxZero multi fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.

Non Pressure Rated: The MaxZero multi fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Indications for use as stated in the FDA summary.

Also cleared against K132413

5 other devices cite the same predicate.

  • K203796Firefly Needleless ConnectorPuracath Medical, Inc. · 2021
  • K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson and Company · 2021
  • K210217Needleless ConnectorJiangsu Caina Medical Co.,Ltd · 2021
  • K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017
  • K143234MaxZero Administration SetsCare Fusion · 2014

More from Care Fusion

34 FDA decisions under this applicant name. See the company

  • K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceCare Fusion · 2024
  • K231888BD Texium™ Needle-Free SyringeCare Fusion · 2023
  • K221327BD Alaris™ Pump Infusion SetsCare Fusion · 2023
  • K221319BD Alaris™ Pump Epidural Infusion SetCare Fusion · 2023
  • K223101BD Secondary Infusion SetCare Fusion · 2023

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K140831 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140831: Maxzero Extension Set with Needless Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140831

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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