510(k) · Cleared
ClearedAbbott Plum a+ Infusion Pump, Model 12391
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · FRN Pump, Infusion
Cleared on Dec 31, 2002 after a 20-day review. The FDA summary names its predicate without a number. 13 of the 35 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it.
- Decided
- Dec 31, 2002
- Review
- 20 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 4 citing it directly. 13 of the 35 devices in this family, counting this one, have a Class I recall.
- This deviceK024084 Abbott Plum a+ Infusion Pump, Model 12391Abbott Laboratories · 2002
- Descendant · cites it directly · 32 of its ownK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- Descendant · 2 generations on · 27 of its ownK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 13 of its ownK041550 Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · Recalled (Class I)
- Descendant · cites it directly · 12 of its ownK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK103224 Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe…Hospira, Inc. · 2011 · Recalled (Class I)
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K070398 Hospira Plum a+ Infusion Pump, Model 12391cites it directly · 2007
- K052052 Hospira Plum a+ Infusion Pump System V11.5…cites it directly · 2005
- K042081 Plum a+ Infusion System with Hospira Mednet…2 generations on · 2004
- K041550 Hospira Phoenix Infusion System with Hospira…2 generations on · 2004
Most influential descendants
Showing 5 of 34 · See all- K031185Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · cites it directly32descendants
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with…Hospira, Inc. · 2004 · 2 generations on27descendants
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 2 generations on13descendants
- K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · cites it directly12descendants
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024084 | Abbott Plum a+ Infusion Pump, Model 12391 | Abbott Laboratories | 2002 | — |
| +1 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| +2 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| +2 | K041550 | Hospira Phoenix Infusion System with Hospira Mednet Software | Abbott Laboratories | 2004 | Class I |
| +1 | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | Class I |
| +2 | K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing | Hospira, Inc. | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 6 | 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 |
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.
13 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
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 | Decided |
|---|---|---|---|
| * | — | Abbott Plum A+ Infusion Pump Named without a submission number |
What descends from it? (34)
See all 344 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | 2003 | 32 |
| K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5 Class I | 2005 | 12 |
| K070398 | Hospira Plum a+ Infusion Pump, Model 12391 Class I | 2007 | 0 |
| K040114 | Abbott Data Port PC, Model 12181 | 2004 | 0 |
Has anything in its family been recalled? (13 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.
- K070398Hospira Plum a+ Infusion Pump, Model 12391Hospira, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 14 Class I recalls
- K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · Cites it directly · ◆ in the 2005 descendants bar of 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 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K041550Hospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 12 Class I recalls
- K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K110901Symbiq Infusion and Adminstration SetHospira, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K081412Plum a+ Hyperbaric Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2008 · 3 generations on · ◆ in the 2008 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 · 3 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 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 14 Class I recalls
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 4 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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
Nearest 12 of 13 shown.
Nearest 5 of 13; all are on the web page.
What does this lineage say?
- Of its descendants, K031185 (Abbott Laboratories, 2003) has gone furthest, with 32 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 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/K024084 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024084: Abbott Plum a+ Infusion Pump, Model 12391.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024084
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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