510(k) · Cleared

Recalled · Class II · 2026

Hospira Primary Sets

K142367510(k) TraditionalCleared Nov 25, 201492-day reviewClass II21 CFR 880.5440Recalls 1

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 Nov 25, 2014 as substantially equivalent to K113683 (Hospira, Inc., 2012) and 1 other predicate after a 92-day review. Its family tree reaches back 4 generations to 2003. 1 of the 14 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.

Decided: Nov 25, 2014
Review: 92 days
Class: Class II
Product code: FPA
Recalls: 1
Predicates: 2

Its longest line of descent runs back 4 generations to K030467 (2003). 9 ancestors in all, the oldest K780880 (1978). 4 later devices descend from it, 2 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
3 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
2 generations backK101677 Hospira Infusion Blood SetsHospira, Inc. · 2010 · Recalled (Class I)
1 generation backK113683 Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012
This deviceK142367 Hospira Primary SetsHospira, Inc. · 2014
Descendant · cites it directly · 3 of its ownK143015 Hospira Primary SetsHospira, Inc. · 2015
Descendant · cites it directly · 1 of its ownK160870 Hospira Administration SetsHospira, Inc. · 2016
Descendant · 2 generations on · 0 of its ownK192375 Intellifuse Administration and Intellifuse Blood Administration SetsSmiths Medical Asd, Inc. · 2020
Descendant · 2 generations on · 0 of its ownK161036 Hospira Extension Set, Hospira Primary SetHospira, Inc. · 2017

Class I recalls in this family

K101677 Hospira Infusion Blood Setsdirect predicate · 2010

Most influential descendants

Showing 4 of 4 · See all

K143015Hospira Primary SetsHospira, Inc. · 2015 · cites it directly3descendants
K160870Hospira Administration SetsHospira, Inc. · 2016 · cites it directly1descendant
K192375Intellifuse Administration and Intellifuse Blood Administration SetsSmiths Medical Asd, Inc. · 2020 · 2 generations on0descendants
K161036Hospira Extension Set, Hospira Primary SetHospira, Inc. · 2017 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K030467	Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set	Iv Medical, Inc.	2003	—
−3	K063239	Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528…	Hospira, Inc.	2006	7
−2	K101677	Hospira Infusion Blood Sets	Hospira, Inc.	2010	Class I
−1	K113683	Lifeshield Vision Infusion Set with Pre-Pierced Reseal	Hospira, Inc.	2012	—
0 (this device)	K142367	Hospira Primary Sets	Hospira, Inc.	2014	—
+1	K143015	Hospira Primary Sets	Hospira, Inc.	2015	—
+1	K160870	Hospira Administration Sets	Hospira, Inc.	2016	—
+2	K192375	Intellifuse Administration and Intellifuse Blood Administration Sets	Smiths Medical Asd, Inc.	2020	—
+2	K161036	Hospira Extension Set, Hospira Primary Set	Hospira, Inc.	2017	—

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
2015	1	0
2016	1	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K142367, 2003–2020Source: 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
*	K113683	Lifeshield Vision Infusion Set with Pre-Pierced Reseal Summary page 4 …Product Code(s) FPA Legally marketed device(s) to Hospira Primary sets: which equivalence is claimed LifeShield Vision Infusion Sets – K113683 Hospira Infusion Blood Sets – K101677 Reason for 510(k) submission The changes address…	Hospira, Inc.	2012	—
*	K101677	Hospira Infusion Blood Sets Summary page 4 …Hospira Primary sets: which equivalence is claimed LifeShield Vision Infusion Sets – K113683 Hospira Infusion Blood Sets – K101677 Reason for 510(k) submission The changes addressed in this submission include: • Mod…	Hospira, Inc.	2010	Class I

Also cleared against K113683: 4 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K143015	Hospira Primary Sets	Hospira, Inc.	2015	3
K160870	Hospira Administration Sets	Hospira, Inc.	2016	1

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2026	Class II	Z-3160-2026	Process control	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration…

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

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
7 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K143015 (Hospira, Inc., 2015) has gone furthest, with 3 descendants of its own.
4 other devices also cite its predicate K113683.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Primary 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/K142367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142367: Hospira Primary Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142367

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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