510(k) · Cleared

Recalled · 2006

Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series

K032147510(k) SpecialCleared Jul 25, 200311-day reviewClass II21 CFR 880.5725Recalls 1

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

Alaris Medical Systems, Inc. · FRN Pump, Infusion

Cleared on Jul 25, 2003 as substantially equivalent to K931549 (Y, 1993) and 1 other predicate after an 11-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled once.

Decided: Jul 25, 2003
Review: 11 days
Class: Class II
Product code: FRN
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K931549 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK931549 Model EZ-1 Sing Chan/EZ-2 Dual Channel Infus PumpY · 1993 · Recalled
This deviceK032147 Signature Edition Infusion Pump, Signature Edition Administration…Alaris Medical Systems, Inc. · 2003
Descendant · cites it directly · 0 of its ownK063288 Signature Edition Gold Infusion System, Model 7X3XCardinal Health 303,Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K063288Signature Edition Gold Infusion System, Model 7X3XCardinal Health 303,Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931549	Model EZ-1 Sing Chan/EZ-2 Dual Channel Infus Pump	Y	1993	1
0 (this device)	K032147	Signature Edition Infusion Pump, Signature Edition Administration Sets, Models…	Alaris Medical Systems, Inc.	2003	—
+1	K063288	Signature Edition Gold Infusion System, Model 7X3X	Cardinal Health 303,Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K032147, 1993–2006Source: 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.

Planning a device in FRN? 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 FRN device

#1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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
*	K931549	Model EZ-1 Sing Chan/EZ-2 Dual Channel Infus Pump Summary page 1 …cessories, FRN (880.5R5) Administration Sets, Intravascular, FPA (880-5440:) PREDICATE DEVICES: EZ 1 and EZ 2 Infusion Pumps, K93 1549 EZ Administration Sets, K93 1550 DEVICE DESCRIPTION This device is essentially the same as the or…	Y	1993	1
*	K931550	EZ Administration Set Summary page 1 …ration Sets, Intravascular, FPA (880-5440:) PREDICATE DEVICES: EZ 1 and EZ 2 Infusion Pumps, K93 1549 EZ Administration Sets, K93 1550 DEVICE DESCRIPTION This device is essentially the same as the originally submitted devices (the predicate devices), filed as Mod…	Y	1994	2

Also cleared against K931549: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K063288	Signature Edition Gold Infusion System, Model 7X3X	Cardinal Health 303,Inc.	2006	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 10, 2006	Not classified	Z-1484-06	Software design	This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K063288 (Cardinal Health 303,Inc., 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K931549.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007high 312 (2013) · low 66 (2009)2026

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

Recalls per year · FRN

7in 2025

2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, 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	12	102	15	1,086
2008	8	89	24	8,261
2009	9	66	102	1,952
2010	3	93	37	6,133
2011	3	103	69	41,367
2012	4	217	42 (2)	15,482
2013	6	312	22 (3)	40,082
2014	6	172	4 (3)	94,180
2015	3	232	5	26,742
2016	3	301	7 (1)	16,560
2017	3	305	13	12,060
2018	3	267	1	16,591
2019	2	—	18 (1)	15,850
2020	1	—	16 (5)	94,186
2021	2	—	3 (2)	199,342
2022	6	268	2	888,020
2023	7	265	16 (10)	165,838
2024	5	103	9 (4)	57,730
2025	8	172	7 (4)	52,792
2026	2	—	11 (2)	—

What is it indicated for?

The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today’s growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.

The Signature Edition Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, centeral, or irrigation of fluid spaces.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032147 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032147: Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032147

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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