510(k) Report

510(k) · Cleared

Recalled · Class I · 2020

Medley Pca Module, Model 8120

K043299510(k) TraditionalCleared Dec 10, 200410-day reviewClass II21 CFR 880.5725Recalls 3 (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. · MEA Pump, Infusion, Pca

Cleared on Dec 10, 2004 as substantially equivalent to K032233 (Alaris Medical Systems, Inc., 2003) after a 10-day review. Its family tree reaches back 1 generation to 2003. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled 3 times, including a Class I recall.

Decided
Dec 10, 2004
Review
10 days
Class
Class II
Product code
MEA
Recalls
3 (1 Class I)
Predicates
1

Its longest line of descent runs back 1 generation to K032233 (2003). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

K032233 · Medley Pca Module, Model 8120 · Alaris Medical Systems, Inc. · 2003 · recalled2000200220042006
K032233 · Medley Pca Module, Model 8120 · Alaris Medical Systems, Inc. · 2003 · recalled0
  1. Root · 1 generation backK032233 Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 2003 · Recalled
  2. This deviceK043299 Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K032233Medley Pca Module, Model 8120Alaris Medical Systems, Inc.20033
0 (this device)K043299Medley Pca Module, Model 8120Alaris Medical Systems, Inc.2004—
FIG. 1 — Lineage of K043299, 2003–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032233Medley Pca Module, Model 8120
Summary page 5
…toring Protocol is of comparable type and is substantially equivalent to the following predicate device: Medley PCA Module ALARIS Medical K032233 Sept. 9, 2003 Systems, Inc. INTENDED USE The Medley PCA Module with PCA/Monitoring…
Alaris Medical Systems, Inc.20033

Also cleared against K032233: 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)

Recalls of this device

DateClassRecallRoot causeReason
Aug 4, 2020Class IZ-2882-2020Component design/selectionThe Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.
Mar 5, 2008Not classifiedZ-1712-2008Device DesignA channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the…
Mar 5, 2008Not classifiedZ-1711-2008Device DesignA channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 2 other devices also cite its predicate K032233.

How does its category compare?

All MEA devices

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

FDA decisions per year · MEA

2in 2017

2008: 12009: 12013: 12016: 12017: 2
2007high 2 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEA

Too few MEA 510(k)s in any year since 2007 to give a median.

Recalls per year · MEA

1in 2024

2008: 12010: 42011: 22014: 12017: 22022: 12024: 1
2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MEA

3,278in 2025

2007: 812008: 2372009: 1532010: 2192011: 2452012: 4462013: 4532014: 3822015: 992016: 572017: 442018: 2562019: 1322020: 2,3312021: 3,7762022: 6,4432023: 3,9842024: 4,5592025: 3,278
2007high 6,443 (2022) · low 44 (2017)2025

MAUDE reports naming product code MEA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—081
20081—1237
20091—0153
20100—4219
20110—2245
20120—0446
20131—0453
20140—1382
20150—099
20161—057
20172—244
20180—0256
20190—0132
20200—02,331
20210—03,776
20220—16,443
20230—03,984
20240—14,559
20250—03,278
20260—0—

What is it indicated for?

The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural. The addition of the PCA/Monitoring Protocol…

Read the full statement (115 words)

The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural.

The addition of the PCA/Monitoring Protocol provides an optional and hospital-configurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

Indications for use as stated in the FDA summary.

Also cleared against K032233

2 other devices cite the same predicate.

  • K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 20094 recalls
  • K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 20091 Class I recall

More from Alaris Medical Systems, Inc.

16 FDA decisions under this applicant name. See the company

  • K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 20041 Class I recall
  • K031741Medley ETCO2 Module (Includes Accessories), Model 8300Alaris Medical Systems, Inc. · 20042 recalls
  • K032233Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20033 recalls
  • K032147Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX, 71XX, 72XX, 7XXXX SeriesAlaris Medical Systems, Inc. · 20031 recall
  • K030459Medley System with Medication Management System (MMS)Alaris Medical Systems, Inc. · 2003

Recent decisions in MEA

The MEA category page

  • K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. · 20175 recalls
  • K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 20175 Class I recalls
  • K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016
  • K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 20131 Class I recall
  • K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 20094 recalls

https://510kreport.com/device/K043299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043299: Medley Pca Module, Model 8120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043299

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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