510(k) Report

510(k) · Cleared

Recalled · Class I · 2026

Alaris Medical Infusion System Administration Sets

K022209510(k) SpecialCleared Aug 6, 200229-day reviewClass II21 CFR 880.5440Recalls 8 (3 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. · FPA Set, Administration, Intravascular

Cleared on Aug 6, 2002 after a 29-day review. The FDA summary names no predicate by number. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 8 times, including 3 Class I recalls.

Decided
Aug 6, 2002
Review
29 days
Class
Class II
Product code
FPA
Recalls
8 (3 Class I)
Predicates
0

3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2023: 1 descendant cleared2004: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK022209 Alaris Medical Infusion System Administration SetsAlaris Medical Systems, Inc. · 2002
  2. Descendant · cites it directly · 1 of its ownK221327 BD Alaris™ Pump Infusion SetsCare Fusion · 2023
  3. Descendant · 2 generations on · 0 of its ownK250325 BD Alaris Pump Infusion SetCarefusion (Bd) · 2025
  4. Descendant · cites it directly · 0 of its ownK041919 Perfudrop Air M-P with Needle 20 G, Model 48451606Clinico · 2004

Most influential descendants

Showing 3 of 3 · See all
  • K221327BD Alaris™ Pump Infusion SetsCare Fusion · 2023 · cites it directly1descendant
  • K250325BD Alaris Pump Infusion SetCarefusion (Bd) · 2025 · 2 generations on0descendants
  • K041919Perfudrop Air M-P with Needle 20 G, Model 48451606Clinico · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022209Alaris Medical Infusion System Administration SetsAlaris Medical Systems, Inc.2002—
+1K221327BD Alaris™ Pump Infusion SetsCare Fusion2023—
+2K250325BD Alaris Pump Infusion SetCarefusion (Bd)2025—
+1K041919Perfudrop Air M-P with Needle 20 G, Model 48451606Clinico2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
202310
202510
FIG. 1 — Lineage of K022209, 2002–2025Source: 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.

Top candidate predicates for a new FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K221327BD Alaris™ Pump Infusion SetsCare Fusion20231
K041919Perfudrop Air M-P with Needle 20 G, Model 48451606Clinico20040

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 19, 2026Class IZ-3080-2026Device DesignDue to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Sep 11, 2025Class IZ-0035-2026Under Investigation by firmInfusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Jul 8, 2025Class IZ-2180-2025Under Investigation by firmInfusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Apr 18, 2024Class IIZ-1944-2024Process controlDue to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
Oct 11, 2023Class IIZ-0349-2024Error in labelingAffected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Oct 11, 2023Class IIZ-0350-2024Error in labelingAffected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Oct 11, 2023Class IIZ-0351-2024Error in labelingAffected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Aug 10, 2006Not classifiedZ-1484-06Software designThis 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.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K221327 (Care Fusion, 2023) 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

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
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

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The following ALARIS Medical Infusion Systems are intended for use in today’s growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize inhsion systems for the delivery of fluids, medications, blood and blood products: IVAC? Signature Edition@Infusion Pumps and Administration Sets. IVAC? MedSystem III@Multi-Channel Inhsion Pump and IVAC MedSystem I I P Multi-Channel Infusion Pump with DLE…

Read the full statement (87 words)

The following ALARIS Medical Infusion Systems are intended for use in today’s growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize inhsion systems for the delivery of fluids, medications, blood and blood products:

IVAC? Signature Edition@Infusion Pumps and Administration Sets.

IVAC? MedSystem III@Multi-Channel Inhsion Pump and IVAC MedSystem I I P Multi-Channel Infusion Pump with DLE and Administration Sets.

IMED@Gemini Infusion Pumps/Controllers and Administration Sets.

ALARIS Medical Medley” Medication Safety System and Administration Sets.

IVAC@,IMED@,and ALARIS@Gravity, Extension, Components, and Secondary Administration Sets.

Indications for use as stated in the FDA summary.

More from Alaris Medical Systems, Inc.

16 FDA decisions under this applicant name. See the company

  • K043299Medley Pca Module, Model 8120Alaris Medical Systems, Inc. · 20041 Class I recall
  • 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

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K022209 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022209: Alaris Medical Infusion System Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022209

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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