510(k) Report

510(k) · Cleared

Cleared

Maxplus Tru-Swab Positive Displacement Connector

K072542510(k) TraditionalCleared Sep 25, 200715-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

Medegen Medical Manufacturing System · FPA Set, Administration, Intravascular

Cleared on Sep 25, 2007 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.

Decided
Sep 25, 2007
Review
15 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
0

27 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2021: 6 descendants cleared2017: 4 descendants cleared2014: 2 descendants cleared2020: 2 descendants cleared2016: 1 descendant cleared2023: 3 descendants cleared2019: 2 descendants cleared2026: 2 descendants cleared2025: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant cleared20052010201520202025
  1. This deviceK072542 Maxplus Tru-Swab Positive Displacement ConnectorMedegen Medical Manufacturing System · 2007
  2. Descendant · cites it directly · 26 of its ownK132413 MZ1000Care Fusion · 2013
  3. Descendant · 2 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
  4. Descendant · 2 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
  5. Descendant · 3 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
  6. Descendant · 3 generations on · 4 of its ownK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22016: 12017: 42019: 22020: 22021: 62022: 12023: 32024: 12025: 22026: 2
2013high 6 (2021) · low 0 (2015)2026

Most influential descendants

Showing 5 of 27 · See all
  • K132413MZ1000Care Fusion · 2013 · cites it directly26descendants
  • K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 2 generations on13descendants
  • K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 2 generations on6descendants
  • K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 3 generations on5descendants
  • K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072542Maxplus Tru-Swab Positive Displacement ConnectorMedegen Medical Manufacturing System2007—
+1K132413MZ1000Care Fusion2013—
+2K140831Maxzero Extension Set with Needless ConnectorCare Fusion2014—
+2K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless…Becton, Dickinson and Company2017—
+3K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20193
+3K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201610
201740
201920
202020
202160
202210
202330
202410
202520
202620
FIG. 1 — Lineage of K072542, 2007–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K132413MZ1000Care Fusion201326

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?

  • Of its descendants, K132413 (Care Fusion, 2013) has gone furthest, with 26 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

The MaxPlus is a sterile single patient use Positive Displacement Connector for needleless access to the IVline and/or IVcatheter during IVtherapy. The MaxPlus connector can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Indications for use as stated in the FDA 510(k) statement.

More from Medegen Medical Manufacturing System

2 FDA decisions under this applicant name. See the company

  • K051939Maxplus Tru-Swab Positive Displacement ConnectorMedegen Medical Manufacturing System · 2005

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https://510kreport.com/device/K072542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072542: Maxplus Tru-Swab Positive Displacement Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072542

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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