510(k) · Cleared
Recalled · 2009Abbott Lifecare Pca 3 Infuser, Model 12384
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · MEA Pump, Infusion, Pca
Cleared on Aug 1, 2002 after a 27-day review. The FDA summary names its predicate without a number. 1 of the 7 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 1, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 3 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- This deviceK022203 Abbott Lifecare Pca 3 Infuser, Model 12384Abbott Laboratories · 2002
- Descendant · cites it directly · 3 of its ownK042800 Lifecare Pca Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK120209 Patient Controlled Analgesia (Pca) Button CableAmerican I.V. Products, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK043256 Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca…Hospira, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK220695 Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022
- Descendant · 2 generations on · 0 of its ownK143612 LifeCare PCA Infusion SystemHospira, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K083019 Gemstar SP Infusion System with Gemstar SP…2 generations on · 2008
Most influential descendants
Showing 5 of 6 · See all- K042800Lifecare Pca Infusion System with Hospira Mednet SoftwareHospira, Inc. · 2004 · cites it directly3descendants
- K120209Patient Controlled Analgesia (Pca) Button CableAmerican I.V. Products, Inc. · 2012 · cites it directly1descendant
- K043256Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System…Hospira, Inc. · 2004 · cites it directly1descendant
- K220695Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022 · 2 generations on0descendants
- K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022203 | Abbott Lifecare Pca 3 Infuser, Model 12384 | Abbott Laboratories | 2002 | — |
| +1 | K042800 | Lifecare Pca Infusion System with Hospira Mednet Software | Hospira, Inc. | 2004 | 5 |
| +1 | K120209 | Patient Controlled Analgesia (Pca) Button Cable | American I.V. Products, Inc. | 2012 | — |
| +1 | K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion… | Hospira, Inc. | 2004 | 4 |
| +2 | K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | 2022 | — |
| +2 | K143612 | LifeCare PCA Infusion System | Hospira, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 1 | 1 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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.
1 device in this family has 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? (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 Lifecare 4100 PCA Infuser Plus II Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2009 | Not classified | Z-0017-2010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
| 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.
- K083019Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareHospira, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K042800 (Hospira, Inc., 2004) has gone furthest, with 3 descendants of its own.
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 Abbott LifeCareB PCA 3 Infuser is indicated for volumetric
infusion of analgesic drugs by continuous or patient demanded
(PCA) intravenous administration. The Abbott Lifecare@ PCA 3
Infuser is also indicated for short-term continuous (less than 96
hours) epidural administration of analgesic drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022203: Abbott Lifecare Pca 3 Infuser, Model 12384.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022203
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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