510(k) · Cleared

Recalled · Class I · 2026

Medley System with Bar Code Module, Model 8600

K041241510(k) TraditionalCleared Jul 6, 200456-day reviewClass II21 CFR 880.5725Recalls 2 (1 Class I)

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 6, 2004 as substantially equivalent to K030459 (Alaris Medical Systems, Inc., 2003) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1990. 3 of the 13 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 2 times, including a Class I recall.

Decided: Jul 6, 2004
Review: 56 days
Class: Class II
Product code: FRN
Recalls: 2 (1 Class I)
Predicates: 2

Its longest line of descent runs back 3 generations to K904518 (1990). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
2 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
1 generation backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
This deviceK041241 Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004
Descendant · cites it directly · 6 of its ownK050883 Safersleep SystemSafer Sleep, LLC · 2005
Descendant · 2 generations on · 5 of its ownK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
Descendant · 3 generations on · 2 of its ownK141474 Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · Recalled
Descendant · 4 generations on · 1 of its ownK182092 BD Intelliport SystemBecton, Dickinson and Company · 2019
Descendant · cites it directly · 1 of its ownK101439 Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005high 2 (2025) · low 0 (2006)2026

Class I recalls in this family

K011975 Horizon Outlook with Dosecomdirect predicate · 2001
K994375 Horizon Light2 generations back · 2000

Most influential descendants

Showing 5 of 7 · See all

K050883Safersleep SystemSafer Sleep, LLC · 2005 · cites it directly6descendants
K062388Anesthesia Information and Digital-Drug Management SystemDocusys · 2007 · 2 generations on5descendants
K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · 3 generations on2descendants
K182092BD Intelliport SystemBecton, Dickinson and Company · 2019 · 4 generations on1descendant
K101439Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K904518	Volumetric Infusion Pump	Kendall Mcgaw Laboratories, Inc.	1990	37
−2	K994375	Horizon Light	B.Braun Medical, Inc.	2000	Class I
−1	K011975	Horizon Outlook with Dosecom	B.Braun Medical, Inc.	2001	Class I
0 (this device)	K041241	Medley System with Bar Code Module, Model 8600	Alaris Medical Systems, Inc.	2004	—
+1	K050883	Safersleep System	Safer Sleep, LLC	2005	—
+2	K062388	Anesthesia Information and Digital-Drug Management System	Docusys	2007	—
+3	K141474	Becton Dickinson Intelliport System	Becton, Dickinson & CO	2014	1
+4	K182092	BD Intelliport System	Becton, Dickinson and Company	2019	—
+1	K101439	Codonics Safe Labeling System (SLS), Model 500I/500P	Codonics, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2011	1	0
2014	1	0
2019	1	0
2025	2	0

FIG. 1 — Lineage of K041241, 1990–2025Source: 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.

3 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.

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

Get a 510(k) Report

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
*	K030459	Medley System with Medication Management System (MMS) Summary page 2 …edicate devices: Predicate Device Manufacturer 510(k) No. Date Cleared Medley System w/ MMS ALARIS Medical K030459 April 4, 2003 __________ _______System s, Inc. Horizon Outlook 200 B. Braun…	Alaris Medical Systems, Inc.	2003	—
*	K011975	Horizon Outlook with Dosecom Summary page 2 …ALARIS Medical K030459 April 4, 2003 __________ _______System s, Inc. Horizon Outlook 200 B. Braun K01 1975 Sept. 19, 2001 ALARIS MEDICAL SYSTEMS®, INC. ORIGINAL PREMARKET 510(K) NOTIFICATI…	B.Braun Medical, Inc.	2001	Class I

Also cleared against K030459: 8 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K050883	Safersleep System	Safer Sleep, LLC	2005	6
K101439	Codonics Safe Labeling System (SLS), Model 500I/500P	Codonics, Inc.	2011	1

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 11, 2026	Class II	Z-1645-2026	Under Investigation by firm	Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
Dec 5, 2013	Class I	Z-0534-2014	Software design	CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

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.

K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K994375Horizon LightB.Braun Medical, Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
3 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K050883 (Safer Sleep, LLC, 2005) has gone furthest, with 6 descendants of its own.
8 other devices also cite its predicate K030459.

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 Medley System with Bar Code Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The Medley System with Bar Code Module is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041241 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041241: Medley System with Bar Code Module, Model 8600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041241

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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