510(k) · Cleared

Recalled · Class II · 2021

EZ Administration Set

K931550510(k) TraditionalCleared Jan 10, 1994287-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

Y · FPA Set, Administration, Intravascular

Cleared on Jan 10, 1994 after a 287-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.

Decided: Jan 10, 1994
Review: 287 days
Class: Class II
Product code: FPA
Recalls: 2
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK931550 EZ Administration SetY · 1994
Descendant · cites it directly · 1 of its ownK032147 Signature Edition Infusion Pump, Signature Edition Administration…Alaris Medical Systems, Inc. · 2003 · Recalled
Descendant · 2 generations on · 0 of its ownK063288 Signature Edition Gold Infusion System, Model 7X3XCardinal Health 303,Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all

K032147Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX…Alaris Medical Systems, Inc. · 2003 · cites it directly1descendant
K063288Signature Edition Gold Infusion System, Model 7X3XCardinal Health 303,Inc. · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K931550	EZ Administration Set	Y	1994	—
+1	K032147	Signature Edition Infusion Pump, Signature Edition Administration Sets, Models…	Alaris Medical Systems, Inc.	2003	1
+2	K063288	Signature Edition Gold Infusion System, Model 7X3X	Cardinal Health 303,Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0

FIG. 1 — Lineage of K931550, 1994–2006Source: 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.

Planning a device in FPA? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K032147	Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX…	Alaris Medical Systems, Inc.	2003	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 2, 2021	Class II	Z-2465-2021	Process control	Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not…
Aug 30, 2013	Class II	Z-2279-2013	Employee error	CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K032147 (Alaris Medical Systems, Inc., 2003) has gone furthest, with 1 descendant 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.

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)	—

https://510kreport.com/device/K931550 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931550: EZ Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931550

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Record history

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