510(k) · Cleared

Cleared

Infusion Sets

K103344510(k) SpecialCleared Dec 10, 201025-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

Hospira, Inc. · FPA Set, Administration, Intravascular

Cleared on Dec 10, 2010 as substantially equivalent to K041550 (Abbott Laboratories, 2004) after a 25-day review. Its family tree reaches back 3 generations to 2001. 6 of the 16 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.

Decided: Dec 10, 2010
Review: 25 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K011442 (2001). 5 ancestors in all. 10 later devices descend from it, 1 citing it directly. 6 of the 16 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
2 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
1 generation backK041550 Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Recalled (Class I)
This deviceK103344 Infusion SetsHospira, Inc. · 2010
Descendant · cites it directly · 9 of its ownK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
Descendant · 2 generations on · 5 of its ownK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
Descendant · 3 generations on · 2 of its ownK223607 Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · Recalled (Class I)
Descendant · 2 generations on · 2 of its ownK153074 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding…Covidien · 2016 · Recalled
Descendant · 3 generations on · 1 of its ownK183311 Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · Recalled (Class I)

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2015high 2 (2025) · low 0 (2018)2026

Class I recalls in this family

K041550 Hospira Phoenix Infusion System with Hospira…direct predicate · 2004
K011442 Abbott Plum a+Infusion Pump, Model 119713 generations back · 2001
K141789 Plum 360 Infusion System with Hospira Mednet…cites it directly · 2015
K161469 Plum 360(TM) Infusion System with MedNet/ Smart…2 generations on · 2017

Most influential descendants

Showing 5 of 10 · See all

K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc. · 2015 · cites it directly9descendants
K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations on5descendants
K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 3 generations on2descendants
K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien · 2016 · 2 generations on2descendants
K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K011442	Abbott Plum a+Infusion Pump, Model 11971	Abbott Laboratories	2001	Class I
−2	K031185	Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module	Abbott Laboratories	2003	4
−1	K041550	Hospira Phoenix Infusion System with Hospira Mednet Software	Abbott Laboratories	2004	Class I
0 (this device)	K103344	Infusion Sets	Hospira, Inc.	2010	—
+1	K141789	Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0…	Hospira, Inc.	2015	Class I
+2	K161469	Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module	Hospira, Inc.	2017	Class I
+3	K223607	Plum Duo™ Infusion System	Icu Medical, Inc.	2023	Class I
+2	K153074	Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets…	Covidien	2016	5
+3	K183311	Ivenix Infusion System (IIS)	Ivenix, Inc.	2019	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	1
2016	1	0
2017	1	1
2019	1	1
2021	1	0
2022	1	0
2023	1	1
2025	2	0
2026	1	0

FIG. 1 — Lineage of K103344, 2001–2026Source: 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.

6 devices in this family have a Class I recall. 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? (1)

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
*	K041550	Hospira Phoenix Infusion System with Hospira Mednet Software Summary page 1 …General Hospital Regulation 21 CFR Part 880.5440 Product Code(s) 80-FPA Legally marketed device(s) to Symbiq sets as cleared in K041 550 which equivalence is claimed Reason for 610(k) submission Back Check Valve component Device description Hospi…	Abbott Laboratories	2004	Class I

Also cleared against K041550: 1 other device →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K141789	Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for… Class I	Hospira, Inc.	2015	9

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls

Nearest 5 of 6; all are on the web page.

What does this lineage say?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K141789 (Hospira, Inc., 2015) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K041550.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

Infusion sets are intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. These sets are intended for use primarily in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/I Surgical Centers, Long Term Care, Urgent Care, Transport and in Physician offices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103344 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103344: Infusion Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103344

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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