510(k) · Cleared

Recalled · Class II · 2026

Medegen Pressure Rated Extension Sets

K083472510(k) TraditionalCleared Dec 9, 200815-day reviewClass II21 CFR 880.5440Recalls 2

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

Medegen, Inc. · FPA Set, Administration, Intravascular

Cleared on Dec 9, 2008 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 32 later devices descend from it. It has been recalled 2 times.

Decided: Dec 9, 2008
Review: 15 days
Class: Class II
Product code: FPA
Recalls: 2
Predicates: 0

32 later devices descend from it, 4 citing it directly.

This deviceK083472 Medegen Pressure Rated Extension SetsMedegen, Inc. · 2008
Descendant · cites it directly · 28 of its ownK120443 Neutral Luer Activated Device and Extension Sets with Neutral Luer…Baxter Healthcare Corporation - Renal Division · 2012
Descendant · 2 generations on · 26 of its ownK132413 MZ1000Care Fusion · 2013
Descendant · cites it directly · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
Descendant · 3 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
Descendant · 4 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2009high 7 (2021) · low 0 (2010)2026

Most influential descendants

Showing 5 of 32 · See all

K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division · 2012 · cites it directly28descendants
K132413MZ1000Care Fusion · 2013 · 2 generations on26descendants
K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · cites it directly13descendants
K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 3 generations on6descendants
K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K083472	Medegen Pressure Rated Extension Sets	Medegen, Inc.	2008	—
+1	K120443	Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated…	Baxter Healthcare Corporation - Renal Division	2012	—
+2	K132413	MZ1000	Care Fusion	2013	—
+1	K140831	Maxzero Extension Set with Needless Connector	Care Fusion	2014	—
+3	K170336	BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless…	Becton, Dickinson and Company	2017	—
+4	K183399	BD Nexiva Closed IV Catheter System	Becton Dickinson Infusion Therapy Systems, Inc.	2019	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	1	0
2013	2	0
2014	3	0
2016	1	0
2017	4	0
2019	2	0
2020	2	0
2021	7	0
2022	1	0
2023	3	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K083472, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
#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? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K120443	Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device	Baxter Healthcare Corporation - Renal Division	2012	28
K140831	Maxzero Extension Set with Needless Connector	Care Fusion	2014	13
K153293	Extension Set	B.Braun Medical, Inc.	2016	3
K090809	MPS Acacia Power Injectable Infusion Set	Mps Acacia	2009	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 16, 2026	Class II	Z-2941-2026	Process control	Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.
May 2, 2019	Class II	Z-0049-2020	Under Investigation by firm	After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K120443 (Baxter Healthcare Corporation - Renal Division, 2012) has gone furthest, with 28 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. 2008, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

The Medegen Pressure Rated Extension Sets are intended for use in today's

growing professional healthcare environment, including healthcare facilities,

home care and medical transport that utilize infusion systems for the delivery of

fluids, medications, blood and blood products. The Medegen Pressure Rated

Extension Sets allow the user to add medication into the primary line without the

use of a needle. The Medegen Pressure Extension Sets may also be used with

low-pressure power injectors rated up to 325 psi.

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

https://510kreport.com/device/K083472 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083472: Medegen Pressure Rated Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083472

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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