510(k) · Cleared
Recalled · Class II · 2013Lifeshield Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Mfg., Inc. · FPK Tubing, Fluid Delivery
Cleared on Oct 3, 1994 after a 207-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 21 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it. It has been recalled 10 times.
- Decided
- Oct 3, 1994
- Review
- 207 days
- Class
- Class II
- Product code
- FPK
- Recalls
- 10
- Predicates
- 0
20 later devices descend from it, 1 citing it directly. 4 of the 21 devices in this family, counting this one, have a Class I recall.
- This deviceK941214 Lifeshield Extension SetAbbott Mfg., Inc. · 1994
- Descendant · cites it directly · 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 · 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)
- Descendant · 2 generations on · 4 of its ownK142974 Extension SetsHospira, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK142367 Hospira Primary SetsHospira, Inc. · 2014 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K113683Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012 · cites it directly19descendants
- 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
- K142974Extension SetsHospira, Inc. · 2015 · 2 generations on4descendants
- K142367Hospira Primary SetsHospira, Inc. · 2014 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941214 | Lifeshield Extension Set | Abbott Mfg., Inc. | 1994 | — |
| +1 | 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 |
| +3 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
| +2 | K142974 | Extension Sets | Hospira, Inc. | 2015 | — |
| +2 | K142367 | Hospira Primary Sets | Hospira, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 1 |
| 2016 | 3 | 0 |
| 2017 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113683 | Lifeshield Vision Infusion Set with Pre-Pierced Reseal | 2012 | 19 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2013 | Class II | Z-1016-2017 | Process control | Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This… |
| Nov 24, 2009 | Not classified | Z-1329-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Sep 29, 2005 | Not classified | Z-0133-06 | Other | Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. |
| Sep 29, 2005 | Not classified | Z-0134-06 | Other | Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. |
| Sep 29, 2005 | Not classified | Z-0135-06 | Other | Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. |
| May 6, 2005 | Not classified | Z-0195-06 | Other | Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. |
| Jun 9, 2003 | Not classified | Z-0956-03 | Other | The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin. |
| Jun 9, 2003 | Not classified | Z-0955-03 | Other | The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin. |
| Jun 9, 2003 | Not classified | Z-0958-03 | Other | The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin. |
| May 13, 2003 | Not classified | Z-0936-03 | Other | The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL |
The 5 latest of 10 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.
- 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, K113683 (Hospira, Inc., 2012) has gone furthest, with 19 descendants of its own.
How does its category compare?
All FPK devicesFPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FPK
Too few FPK 510(k)s in any year since 2007 to give a median.
Recalls per year · FPK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPK
30in 2025
MAUDE reports naming product code FPK, 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 | 1 | — | 0 | 29 |
| 2008 | 0 | — | 9 | 78 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 67 |
| 2011 | 0 | — | 0 | 112 |
| 2012 | 0 | — | 14 | 107 |
| 2013 | 1 | — | 1 | 29 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 1 | 15 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K941214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941214: Lifeshield Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941214
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026