510(k) · Cleared

Cleared

Hospira Extension Sets

K151969510(k) TraditionalCleared Jan 19, 2016187-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

Icu Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Jan 19, 2016 as substantially equivalent to K142974 (Hospira, Inc., 2015) and 1 other predicate after a 187-day review. Its family tree reaches back 5 generations to 2003. 1 of the 12 devices in its family, counting itself, has a Class I recall.

Decided: Jan 19, 2016
Review: 187 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K030467 (2003). 11 ancestors in all, the oldest K780880 (1978). No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 5 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
4 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
3 generations backK101677 Hospira Infusion Blood SetsHospira, Inc. · 2010 · Recalled (Class I)
2 generations backK113683 Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012
1 generation backK142433 Hospira Extension SetHospira, Inc. · 2014
This deviceK151969 Hospira Extension SetsIcu Medical, Inc. · 2016

Class I recalls in this family

K101677 Hospira Infusion Blood Sets2 generations back · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K030467	Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set	Iv Medical, Inc.	2003	—
−4	K063239	Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528…	Hospira, Inc.	2006	7
−3	K101677	Hospira Infusion Blood Sets	Hospira, Inc.	2010	Class I
−2	K113683	Lifeshield Vision Infusion Set with Pre-Pierced Reseal	Hospira, Inc.	2012	—
−1	K142433	Hospira Extension Set	Hospira, Inc.	2014	—
0 (this device)	K151969	Hospira Extension Sets	Icu Medical, Inc.	2016	—

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
2015	1	0

FIG. 1 — Lineage of K151969, 2003–2016Source: 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.

1 device in this family has 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

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What was it cleared against? (2)

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
*	K142974	Extension Sets Summary page 4 …n name Intravascular Administration Set, 21 CFR 880.5440, Class II Product Code(s) FPA Legally marketed device(s) to Extension Sets – K142974 which equivalence is claimed Hospira Extension Sets – K142433 Reason for 510(k) submission The changes addressed in…	Hospira, Inc.	2015	—
*	K142433	Hospira Extension Set Summary page 4 …ass II Product Code(s) FPA Legally marketed device(s) to Extension Sets – K142974 which equivalence is claimed Hospira Extension Sets – K142433 Reason for 510(k) submission The changes addressed in this submission include: 1. Hosp…	Hospira, Inc.	2014	—
†	K970855	Clave Connector	Icu Medical, Inc.	1997	52

Also cleared against K142974: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 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 · 2 generations back · ◆ on the line of descent in FIG. 18 Class I recalls

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
7 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
2 other devices also cite its predicate K142974.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

Hospira Extension sets are indicated 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/K151969 · printed Nov 4, 2026

Cite this page

510(k) Report. “K151969: Hospira Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151969

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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