510(k) · Cleared
Recalled · Class II · 2013Abbott Plum a+3 Multichannel Infusion Pump, Model 12348
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · FRN Pump, Infusion
Cleared on May 14, 2002 after a 15-day review. The FDA summary names its predicate without a number. 11 of the 30 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it. It has been recalled 6 times.
- Decided
- May 14, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 6
- Predicates
- 0
29 later devices descend from it, 3 citing it directly. 11 of the 30 devices in this family, counting this one, have a Class I recall.
- This deviceK021350 Abbott Plum a+3 Multichannel Infusion Pump, Model 12348Abbott Laboratories · 2002
- 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 · 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)
- Descendant · 2 generations on · 9 of its ownK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K042081 Plum a+ Infusion System with Hospira Mednet…cites it directly · 2004
- K052052 Hospira Plum a+ Infusion Pump System V11.5…cites it directly · 2005
- K081412 Plum a+ Hyperbaric Infusion System with Hospira…2 generations on · 2008
- K141789 Plum 360 Infusion System with Hospira Mednet…2 generations on · 2015
Most influential descendants
Showing 5 of 29 · See all- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with…Hospira, Inc. · 2004 · cites it directly27descendants
- 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
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc. · 2015 · 2 generations on9descendants
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021350 | Abbott Plum a+3 Multichannel Infusion Pump, Model 12348 | Abbott Laboratories | 2002 | — |
| +1 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 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 |
| +2 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| +3 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 1 |
| 2005 | 1 | 1 |
| 2007 | 1 | 1 |
| 2008 | 2 | 2 |
| 2011 | 1 | 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.
11 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+™ Single Channel Infusion Pump Named without a submission number |
What descends from it? (29)
See all 293 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2013 | Class II | Z-0286-2014 | Component design/selection | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and… |
| Dec 7, 2012 | Class II | Z-0625-2013 | Device Design | The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. |
| Feb 5, 2012 | Class II | Z-0206-2014 | Nonconforming Material/Component | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186… |
| Aug 11, 2009 | Not classified | Z-0023-2010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
| Sep 8, 2004 | Not classified | Z-0439-05 | Other | The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power. |
| Sep 8, 2004 | Not classified | Z-0438-05 | Other | The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power. |
The 5 latest of 6 recalls; the web page lists all.
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.
- 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
- 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
- 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
- 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
- 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
- K070398Hospira Plum a+ Infusion Pump, Model 12391Hospira, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 14 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
- 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
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- Of its descendants, K042081 (Hospira, Inc., 2004) has gone furthest, with 27 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021350: Abbott Plum a+3 Multichannel Infusion Pump, Model 12348.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021350
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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