510(k) · Cleared

Cleared

Lifeshield Vision Infusion Set with Pre-Pierced Reseal

K113683510(k) SpecialCleared Jan 12, 201228-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hospira, Inc. · FPA Set, Administration, Intravascular

Cleared on Jan 12, 2012 as substantially equivalent to K941214 (Abbott Mfg., Inc., 1994) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 2003. 5 of the 28 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it.

Decided: Jan 12, 2012
Review: 28 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K030467 (2003). 8 ancestors in all, the oldest K780880 (1978). 19 later devices descend from it, 5 citing it directly. 5 of the 28 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
2 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
1 generation backK101677 Hospira Infusion Blood SetsHospira, Inc. · 2010 · Recalled (Class I)
This deviceK113683 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 · cites it directly · 4 of its ownK142974 Extension SetsHospira, Inc. · 2015
Descendant · cites it directly · 4 of its ownK142367 Hospira Primary SetsHospira, Inc. · 2014 · Recalled
Descendant · 2 generations on · 3 of its ownK143015 Hospira Primary SetsHospira, Inc. · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2014high 4 (2015) · low 0 (2018)2026

Class I recalls in this family

K101677 Hospira Infusion Blood Setsdirect predicate · 2010
K141789 Plum 360 Infusion System with Hospira Mednet…cites it directly · 2015
K161469 Plum 360(TM) Infusion System with MedNet/ Smart…2 generations on · 2017
K223607 Plum Duo™ Infusion System3 generations on · 2023

Most influential descendants

Showing 5 of 19 · See all

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 · cites it directly4descendants
K142367Hospira Primary SetsHospira, Inc. · 2014 · cites it directly4descendants
K143015Hospira Primary SetsHospira, Inc. · 2015 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K030467	Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set	Iv Medical, Inc.	2003	—
−2	K063239	Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528…	Hospira, Inc.	2006	7
−1	K101677	Hospira Infusion Blood Sets	Hospira, Inc.	2010	Class I
0 (this device)	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
+1	K142974	Extension Sets	Hospira, Inc.	2015	—
+1	K142367	Hospira Primary Sets	Hospira, Inc.	2014	1
+2	K143015	Hospira Primary Sets	Hospira, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1991	1	0
1994	1	0
2003	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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

FIG. 1 — Lineage of K113683, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K941214	Lifeshield Extension Set Summary page 1 …ass 11 Regulation 21-CFR Part 880.5440 Product Code(s) 80-FPA Legally marketed device(s) to K941214 LIFESHIELD Extension Set 10/03/1994 which equivalence is claimed K052722 LIFESHIE…	Abbott Mfg., Inc.	1994	10
*	K052722	Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others Summary page 1 …FPA Legally marketed device(s) to K941214 LIFESHIELD Extension Set 10/03/1994 which equivalence is claimed K052722 LIFESHIELD Latex Free Microbore Extension Set 11/02/2005 K101677 Hospira…	Hospira, Inc.	2005	1
*	K101677	Hospira Infusion Blood Sets Summary page 1 …994 which equivalence is claimed K052722 LIFESHIELD Latex Free Microbore Extension Set 11/02/2005 K101677 Hospira Infusion Blood Sets 08/11/2010 The changes addr…	Hospira, Inc.	2010	Class I

What descends from it? (19)

See all 19

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K141789	Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for… Class I	Hospira, Inc.	2015	9
K142974	Extension Sets	Hospira, Inc.	2015	4
K142367	Hospira Primary Sets	Hospira, Inc.	2014	4
K142433	Hospira Extension Set	Hospira, Inc.	2014	3
K142622	IV Administration	Hospira, Inc.	2015	2

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

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 · Direct predicate · ◆ on the line of descent in 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 · 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?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
7 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K141789 (Hospira, Inc., 2015) has gone furthest, with 9 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)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?

LIFESHIELD VISION Infusion sets are intended for the delivery of fluids including but not limited to blood and blood products from a container into a patients vascular system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113683

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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