510(k) · Cleared
Recalled · Class I · 2014Plum a+ Hyperbaric Infusion System with Hospira Mednet Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FRN Pump, Infusion
Cleared on Dec 17, 2008 as substantially equivalent to K042081 (Hospira, Inc., 2004) and 1 other predicate after a 211-day review. Its family tree reaches back 3 generations to 2001. 3 of the 7 devices in its family, counting itself, have a Class I recall. It has been recalled 17 times, including a Class I recall.
- Decided
- Dec 17, 2008
- Review
- 211 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 17 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011442 (2001). 6 ancestors in all, the oldest K890282 (1989). No later device cites it as a predicate yet. 3 of the 7 devices in this family, counting this one, have a Class I recall.
- 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 backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- This deviceK081412 Plum a+ Hyperbaric Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2008
Class I recalls in this family
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 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| 0 (this device) | K081412 | Plum a+ Hyperbaric Infusion System with Hospira Mednet Software | Hospira, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2002 | 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.
3 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? (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 | Decided |
|---|---|---|---|
| * | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with…Summary page 1…Proposed Device: MedNete Software 5. Predicate Devices: Plum A+ Infusion System with Hospira MedNet Software (K042081) Abbott LifeCaree Model 3 HB Pump (K890282) 6. Proposed Device Description: The Plu… | 2004 |
| * | K890282 | Resubmitted Abbott Lifecare Model 3 HB PumpSummary page 1…Plum A+ Infusion System with Hospira MedNet Software (K042081) Abbott LifeCaree Model 3 HB Pump (K890282) 6. Proposed Device Description: The Plum A+8 Hyperbaric Infusion System with Hospira MedNeto Software is an… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2014 | Class I | Z-1074-2015 | Component change control | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. |
| Feb 6, 2013 | Class II | Z-2728-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 6, 2013 | Class II | Z-2722-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 6, 2013 | Class II | Z-2724-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 6, 2013 | Class II | Z-2730-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 6, 2013 | Class II | Z-2727-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 6, 2013 | Class II | Z-2725-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 6, 2013 | Class II | Z-2729-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 6, 2013 | Class II | Z-2723-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 6, 2013 | Class II | Z-2726-2016 | Nonconforming Material/Component | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. |
| Feb 1, 2013 | Class II | Z-0283-2014 | 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-0626-2013 | 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. |
| Oct 26, 2012 | Class II | Z-0482-2013 | 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… |
| Feb 5, 2012 | Class II | Z-0203-2014 | 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… |
| Sep 16, 2011 | Not classified | Z-0011-2012 | 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-3286-2011 | 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-1646-2011 | 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. |
The 5 latest of 17 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 · Direct predicate · ◆ on the line of descent in FIG. 14 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
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- 5 other devices also cite its predicate K042081.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
The Plum A+ Hyperbaric Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Additionally, the Plum A+ Hyperbaric Infusion System with Hospira MedNet Software can be used under hyperbaric conditions in multiplace and monoplace (Class A and B) chambers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081412: Plum a+ Hyperbaric Infusion System with Hospira Mednet Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081412
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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