510(k) · Cleared

Recalled · Class II · 2012

Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module

K031185510(k) TraditionalCleared Apr 30, 200315-day reviewClass II21 CFR 880.5725Recalls 4

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

Abbott Laboratories · FRN Pump, Infusion

Cleared on Apr 30, 2003 as substantially equivalent to K011442 (Abbott Laboratories, 2001) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 2001. 14 of the 35 devices in its family, counting itself, have a Class I recall. 32 later devices descend from it. It has been recalled 4 times.

Decided: Apr 30, 2003
Review: 15 days
Class: Class II
Product code: FRN
Recalls: 4
Predicates: 2

Its longest line of descent runs back 1 generation to K011442 (2001). 2 ancestors in all. 32 later devices descend from it, 2 citing it directly. 14 of the 35 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
This deviceK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003
Descendant · cites it directly · 27 of its ownK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
Descendant · cites it directly · 13 of its ownK041550 Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Recalled (Class I)
Descendant · 2 generations on · 12 of its ownK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
Descendant · 3 generations on · 10 of its ownK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
Descendant · 2 generations on · 10 of its ownK103344 Infusion SetsHospira, Inc. · 2010

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2004high 5 (2004) · low 0 (2006)2026

Class I recalls in this family

K011442 Abbott Plum a+Infusion Pump, Model 11971direct predicate · 2001
K042081 Plum a+ Infusion System with Hospira Mednet…cites it directly · 2004
K041550 Hospira Phoenix Infusion System with Hospira…cites it directly · 2004
K110901 Symbiq Infusion and Adminstration Set2 generations on · 2012

Most influential descendants

Showing 5 of 32 · See all

K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with…Hospira, Inc. · 2004 · cites it directly27descendants
K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · cites it directly13descendants
K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · 2 generations on12descendants
K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 3 generations on10descendants
K103344Infusion SetsHospira, Inc. · 2010 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011442	Abbott Plum a+Infusion Pump, Model 11971	Abbott Laboratories	2001	Class I
0 (this device)	K031185	Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module	Abbott Laboratories	2003	—
+1	K042081	Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion…	Hospira, Inc.	2004	Class I
+1	K041550	Hospira Phoenix Infusion System with Hospira Mednet Software	Abbott Laboratories	2004	Class I
+2	K052052	Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump…	Hospira, Inc.	2005	Class I
+3	K103224	Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing	Hospira, Inc.	2011	Class I
+2	K103344	Infusion Sets	Hospira, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	5	2
2005	1	1
2007	1	1
2008	2	2
2010	1	0
2011	1	1
2012	2	1
2014	2	0
2015	1	1
2016	2	0
2017	2	1
2019	1	1
2020	1	1
2021	1	0
2022	1	0
2023	3	1
2025	3	0
2026	2	0

FIG. 1 — Lineage of K031185, 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.

14 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 FRN device

#1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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? (2)

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
*	K011442	Abbott Plum a+Infusion Pump, Model 11971	Abbott Laboratories	2001	Class I
*	K024084	Abbott Plum a+ Infusion Pump, Model 12391 Summary page 1 …Play Module 5. Predicate Device: Abbott Plum A+TMInfusion Pump (KO11442) Abbott Plum A+* Infusion Pump (K024084) 6. Proposed Device Description: The Abbott Plum A+* Infusion Pump is an electromechanical infusion pump that u…	Abbott Laboratories	2002	—

Also cleared against K011442: 2 other devices →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K042081	Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with… Class I	Hospira, Inc.	2004	27
K041550	Hospira Phoenix Infusion System with Hospira Mednet Software Class I	Abbott Laboratories	2004	13

Has anything in its family been recalled? (14 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 26, 2012	Class II	Z-0481-2013	Device Design	The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a…
Sep 16, 2011	Not classified	Z-0010-2012	Software design	Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This…
Sep 16, 2011	Not classified	Z-3285-2011	Nonconforming Material/Component	Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged…
Feb 14, 2011	Not classified	Z-1645-2011	Nonconforming Material/Component	Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.

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.

K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 12 Class I recalls
K110901Symbiq Infusion and Adminstration SetHospira, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
K081412Plum a+ Hyperbaric Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · 2 generations on · ◆ in the 2005 descendants bar of 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 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
K083019Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareHospira, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 14 Class I recalls
K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K070398Hospira Plum a+ Infusion Pump, Model 12391Hospira, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls
K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls

Nearest 12 of 14 shown.

Nearest 5 of 14; all are on the web page.

What does this lineage say?

1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K042081 (Hospira, Inc., 2004) has gone furthest, with 27 descendants of its own.
2 other devices also cite its predicate K011442.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007high 312 (2013) · low 66 (2009)2026

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

Recalls per year · FRN

7in 2025

2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, 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	12	102	15	1,086
2008	8	89	24	8,261
2009	9	66	102	1,952
2010	3	93	37	6,133
2011	3	103	69	41,367
2012	4	217	42 (2)	15,482
2013	6	312	22 (3)	40,082
2014	6	172	4 (3)	94,180
2015	3	232	5	26,742
2016	3	301	7 (1)	16,560
2017	3	305	13	12,060
2018	3	267	1	16,591
2019	2	—	18 (1)	15,850
2020	1	—	16 (5)	94,186
2021	2	—	3 (2)	199,342
2022	6	268	2	888,020
2023	7	265	16 (10)	165,838
2024	5	103	9 (4)	57,730
2025	8	172	7 (4)	52,792
2026	2	—	11 (2)	—

What is it indicated for?

Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031185 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031185: Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031185

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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