510(k) · Cleared
Recalled · Class II · 2013Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · MEA Pump, Infusion, Pca
Cleared on Dec 6, 2004 as substantially equivalent to K042800 (Hospira, Inc., 2004) and 1 other predicate after a 12-day review. Its family tree reaches back 4 generations to 2001. 2 of the 9 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Dec 6, 2004
- Review
- 12 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 4 generations to K011442 (2001). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 3 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 2 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 1 generation backK042800 Lifecare Pca Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2004 · Recalled
- This deviceK043256 Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca…Hospira, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK143612 LifeCare PCA Infusion SystemHospira, Inc. · 2016
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −3 | 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 |
| −1 | K042800 | Lifecare Pca Infusion System with Hospira Mednet Software | Hospira, Inc. | 2004 | 5 |
| 0 (this device) | K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion… | Hospira, Inc. | 2004 | — |
| +1 | K143612 | LifeCare PCA Infusion System | Hospira, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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.
2 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K042800 | Lifecare Pca Infusion System with Hospira Mednet SoftwareSummary page 2…r use as predicates are summarized in the following table. 510(k) # Product Name Clearance Date K042800 LifeCare PCA' Infusion System with Hospira MedNetTM 10/28/2004 Software K022203 Ab… | 2004 |
| * | K022203 | Abbott Lifecare Pca 3 Infuser, Model 12384Summary page 2…Clearance Date K042800 LifeCare PCA' Infusion System with Hospira MedNetTM 10/28/2004 Software K022203 Abbott LifeCare* PCA3 infusion System 08/01/2002 11. Comparison to Legally Marketed Device(s)… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143612 | LifeCare PCA Infusion System | 2016 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2013 | Class II | Z-2140-2016 | Component design/selection | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw)… |
| Feb 27, 2013 | Class II | Z-1517-2015 | Device Design | The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication. |
| Aug 2, 2012 | Class II | Z-2346-2012 | Nonconforming Material/Component | Reports of leaking during filling and administration. |
| Nov 2, 2005 | Not classified | Z-0601-06 | Other | Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen. |
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 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K143612 (Hospira, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K042800.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEA
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MEA
Too few MEA 510(k)s in any year since 2007 to give a median.
Recalls per year · MEA
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEA
3,278in 2025
MAUDE reports naming product code MEA, 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 | 0 | — | 0 | 81 |
| 2008 | 1 | — | 1 | 237 |
| 2009 | 1 | — | 0 | 153 |
| 2010 | 0 | — | 4 | 219 |
| 2011 | 0 | — | 2 | 245 |
| 2012 | 0 | — | 0 | 446 |
| 2013 | 1 | — | 0 | 453 |
| 2014 | 0 | — | 1 | 382 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 57 |
| 2017 | 2 | — | 2 | 44 |
| 2018 | 0 | — | 0 | 256 |
| 2019 | 0 | — | 0 | 132 |
| 2020 | 0 | — | 0 | 2,331 |
| 2021 | 0 | — | 0 | 3,776 |
| 2022 | 0 | — | 1 | 6,443 |
| 2023 | 0 | — | 0 | 3,984 |
| 2024 | 0 | — | 1 | 4,559 |
| 2025 | 0 | — | 0 | 3,278 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hospira LifeCare® PCA3 Infusion System is indicated for accurate,
volumetric, infusion of analgesic drugs by continuous or patient-demanded
(PCA) intravenous administration. The LifeCare PCA® Infusion System is also
indicated for short-term (less than 96 hours) continuous epidural administration
of analgesic drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043256 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043256: Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043256
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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