510(k) · Cleared
Recalled · 2009Lifeshield Primary IV Set Conv. Pin. Clave; LF LC 5000 Plumset-Dual W/Conv Pin & Cap Port; Lifeshield LF Macrobore Ext.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · FPA Set, Administration, Intravascular
Cleared on Jan 27, 2003 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 of the 32 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled 29 times.
- Decided
- Jan 27, 2003
- Review
- 25 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 29
- Predicates
- 0
31 later devices descend from it, 1 citing it directly. 5 of the 32 devices in this family, counting this one, have a Class I recall.
- This deviceK030002 Lifeshield Primary IV Set Conv. Pin. Clave; LF LC 5000 Plumset-Dual…Abbott Laboratories · 2003
- Descendant · cites it directly · 30 of its ownK101677 Hospira Infusion Blood SetsHospira, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 19 of its ownK113683 Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012
- 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 · 2 generations on · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
- 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 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · cites it directly30descendants
- K113683Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012 · 2 generations on19descendants
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc. · 2015 · 2 generations on9descendants
- K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · 2 generations on6descendants
- 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) | K030002 | Lifeshield Primary IV Set Conv. Pin. Clave; LF LC 5000 Plumset-Dual W/Conv Pin… | Abbott Laboratories | 2003 | — |
| +1 | K101677 | Hospira Infusion Blood Sets | Hospira, Inc. | 2010 | Class I |
| +2 | K113683 | Lifeshield Vision Infusion Set with Pre-Pierced Reseal | Hospira, Inc. | 2012 | — |
| +2 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| +2 | K140838 | IV Administration Set with Hand Pump | B.Braun Medical, Inc. | 2014 | — |
| +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 |
|---|---|---|
| 2010 | 1 | 1 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 1 |
| 2016 | 4 | 0 |
| 2017 | 3 | 1 |
| 2019 | 1 | 1 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101677 | Hospira Infusion Blood Sets Class I | 2010 | 30 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2009 | Not classified | Z-1385-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1365-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1377-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1335-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1346-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1381-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1369-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1334-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1328-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1375-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1373-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1347-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1372-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1374-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1376-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1380-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1386-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1348-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1366-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1371-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1370-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1367-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1379-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1362-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1378-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1363-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1332-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1368-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1361-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
The 5 latest of 29 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.
- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 18 Class I recalls
- 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
- 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
What does this lineage say?
- Of its descendants, K101677 (Hospira, Inc., 2010) has gone furthest, with 30 descendants of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
For administration of I.V. fluids from a container to a patient’s vascular system. The safety feature of this device aids in the prevention of needlestick injuries.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030002 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030002: Lifeshield Primary IV Set Conv. Pin. Clave; LF LC 5000 Plumset-Dual W/Conv Pin & Cap Port; Lifeshield LF Macrobore Ext..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030002
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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