510(k) · Decided
Recalled · 2010Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FPA Set, Administration, Intravascular
Cleared on Nov 2, 2005 as substantially equivalent to K912103 (Abbott Laboratories, 1991) after a 34-day review. Its family tree reaches back 1 generation to 1991. 4 of the 23 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912103 (1991). 21 later devices descend from it, 4 citing it directly. 4 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK912103 Lifeshield Extension SetAbbott Laboratories · 1991 · Recalled
- This deviceK052722 Lifeshield Latex-Free Microbore Extension Set, Model 14949 and OthersHospira, Inc. · 2005
- Descendant · cites it directly · 19 of its ownK113683 Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012
- Descendant · cites it directly · 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 · 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 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · 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 · cites it directly9descendants
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 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 |
|---|---|---|---|---|---|
| −1 | K912103 | Lifeshield Extension Set | Abbott Laboratories | 1991 | 2 |
| 0 (this device) | K052722 | Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others | Hospira, Inc. | 2005 | — |
| +1 | K113683 | Lifeshield Vision Infusion Set with Pre-Pierced Reseal | Hospira, Inc. | 2012 | — |
| +1 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| +2 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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), 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.
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.
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? (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 |
|---|---|---|---|
| * | K912103 | Lifeshield Extension SetSummary page 1…atex-Free, Primary IV Pump Set with Distal Microbore Patient Line (K033576) and is substantially equivalent to the predicate LifeShield® Microbore Extension Set (K.912103) with respect to the following characteristics: Similarities: 1) The extension sets are intended for the delivery o… | 1991 |
| † | K033576 | Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible… | 2003 |
What descends from it? (21)
See all 214 later devices cite 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 |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for… Class I | 2015 | 9 |
| K142433 | Hospira Extension Set | 2014 | 3 |
| K093271 | Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration… | 2010 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2010 | Not classified | Z-0809-2010 | Process control | There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure. |
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 · Cites it directly · ◆ 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 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K113683 (Hospira, Inc., 2012) has gone furthest, with 19 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?
The LifeShield® Latex-Free Microbore Extension Set is intended for the delivery of fluids from a container to a patient's vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052722: Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052722
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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