510(k) · Cleared

Recalled · 2009

Lifeshield Extension Set

K912103510(k) TraditionalCleared Dec 13, 1991214-day reviewClass II21 CFR 880.5440Recalls 2

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

Abbott Laboratories · FPK Tubing, Fluid Delivery

Cleared on Dec 13, 1991 after a 214-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 23 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it. It has been recalled 2 times.

Decided: Dec 13, 1991
Review: 214 days
Class: Class II
Product code: FPK
Recalls: 2
Predicates: 0

22 later devices descend from it, 1 citing it directly. 4 of the 23 devices in this family, counting this one, have a Class I recall.

This deviceK912103 Lifeshield Extension SetAbbott Laboratories · 1991
Descendant · cites it directly · 21 of its ownK052722 Lifeshield Latex-Free Microbore Extension Set, Model 14949 and OthersHospira, Inc. · 2005 · Recalled
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 · 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 · 3 generations on · 4 of its ownK142974 Extension SetsHospira, Inc. · 2015

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005high 4 (2015) · low 0 (2006)2026

Class I recalls in this family

K141789 Plum 360 Infusion System with Hospira Mednet…2 generations on · 2015
K161469 Plum 360(TM) Infusion System with MedNet/ Smart…3 generations on · 2017
K223607 Plum Duo™ Infusion System4 generations on · 2023
K183311 Ivenix Infusion System (IIS)4 generations on · 2019

Most influential descendants

Showing 5 of 22 · See all

K052722Lifeshield Latex-Free Microbore Extension Set, Model 14949 and OthersHospira, Inc. · 2005 · cites it directly21descendants
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
K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 3 generations on5descendants
K142974Extension SetsHospira, Inc. · 2015 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K912103	Lifeshield Extension Set	Abbott Laboratories	1991	—
+1	K052722	Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others	Hospira, Inc.	2005	1
+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
+3	K161469	Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module	Hospira, Inc.	2017	Class I
+3	K142974	Extension Sets	Hospira, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
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

FIG. 1 — Lineage of K912103, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052722	Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others	Hospira, Inc.	2005	21

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 24, 2009	Not classified	Z-1388-2010	Component design/selection	Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Jun 9, 2003	Not classified	Z-0959-03	Other	The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

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, K052722 (Hospira, Inc., 2005) has gone furthest, with 21 descendants of its own.

How does its category compare?

All FPK devices

FPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPK

1in 2013

2007high 1 (2007) · low 0 (2008)2026

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

2007high 14 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FPK

30in 2025

2007high 112 (2011) · low 4 (2020)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/K912103 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912103: 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/K912103

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026