510(k) Report

510(k) · Cleared

Recalled · Class I · 2019

Tubing Sets for Baxa Exacta-Med Pharmacy Pump

K900585510(k) TraditionalCleared Apr 18, 199070-day reviewClass II21 CFR 880.5440Recalls 37 (1 Class I)

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

Baxa Corp., Sub. of Cook Group, Inc. · LHI Set, I.V. Fluid Transfer

Cleared on Apr 18, 1990 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 37 times, including a Class I recall.

Decided
Apr 18, 1990
Review
70 days
Class
Class II
Product code
LHI
Recalls
37 (1 Class I)
Predicates
0

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

Descendants, by year cleared 2018: 1 descendant cleared1990200020102020
  1. This deviceK900585 Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK173577 Guarded Luer ConnectorInternational Medical Industries, Inc. · 2018 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K173577Guarded Luer ConnectorInternational Medical Industries, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K900585Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc.1990—
+1K173577Guarded Luer ConnectorInternational Medical Industries, Inc.20181

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K900585, 1990–2018Source: 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), 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 LHI device

  1. #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K173577Guarded Luer ConnectorInternational Medical Industries, Inc.20180

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 18, 2019Class IIZ-0167-2020Process controlPotential ability to leak once used for compounding.
Sep 12, 2018Class IIZ-0364-2019Process controlPotential ability to leak once used for compounding.
Sep 12, 2018Class IIZ-0367-2019Process controlPotential ability to leak once used for compounding.
Sep 12, 2018Class IIZ-0363-2019Process controlPotential ability to leak once used for compounding.
Sep 12, 2018Class IIZ-0366-2019Process controlPotential ability to leak once used for compounding.
Sep 12, 2018Class IIZ-0365-2019Process controlPotential ability to leak once used for compounding.
Aug 24, 2016Class IZ-0007-2017Nonconforming Material/ComponentBaxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to…
Aug 22, 2013Class IIZ-2165-2013Labeling Change ControlBaxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.
Mar 8, 2011Not classifiedZ-1963-2011Nonconforming Material/ComponentTPN bags may leak during filling operation, due to bag manufacturing error.
Mar 8, 2011Not classifiedZ-1965-2011Nonconforming Material/ComponentTPN bags may leak during filling operation, due to bag manufacturing error.
Mar 8, 2011Not classifiedZ-1962-2011Nonconforming Material/ComponentTPN bags may leak during filling operation, due to bag manufacturing error.
Mar 8, 2011Not classifiedZ-1964-2011Nonconforming Material/ComponentTPN bags may leak during filling operation, due to bag manufacturing error.
Mar 8, 2011Not classifiedZ-1966-2011Nonconforming Material/ComponentTPN bags may leak during filling operation, due to bag manufacturing error.
Mar 8, 2011Not classifiedZ-1967-2011Nonconforming Material/ComponentTPN bags may leak during filling operation, due to bag manufacturing error.
May 26, 2010Not classifiedZ-2142-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2138-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2141-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2140-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2146-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2148-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2137-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2145-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2143-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2139-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2147-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
May 26, 2010Not classifiedZ-2144-2010Process designFill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.
Nov 12, 2009Not classifiedZ-1030-2010Process controlTPN bags may leak fluid due to inadequate sealing.
Nov 12, 2009Not classifiedZ-1031-2010Process controlTPN bags may leak fluid due to inadequate sealing.
Nov 12, 2009Not classifiedZ-1032-2010Process controlTPN bags may leak fluid due to inadequate sealing.
May 8, 2009Not classifiedZ-1420-2012Labeling False and MisleadingSpike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
Apr 30, 2004Not classifiedZ-0979-04OtherA potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
Apr 30, 2004Not classifiedZ-0978-04OtherA potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
Apr 30, 2004Not classifiedZ-0981-04OtherA potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
Apr 30, 2004Not classifiedZ-0983-04OtherA potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
Apr 30, 2004Not classifiedZ-0980-04OtherA potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
Apr 30, 2004Not classifiedZ-0982-04OtherA potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
Apr 30, 2004Not classifiedZ-0984-04OtherA potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.

The 5 latest of 37 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K173577 (International Medical Industries, Inc., 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LHI devices

LHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LHI

6in 2025

2007: 32008: 42009: 82010: 52011: 32012: 52013: 42014: 62015: 32016: 32017: 52018: 12019: 42020: 32021: 32022: 62023: 52024: 92025: 62026 (partial year): 2
2007high 9 (2024) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHI

196in 2025

2007: 89 days median2008: 154 days median2009: 95 days median2010: 139 days median2011: 99 days median2012: 127 days median2013: 102 days median2014: 63 days median2015: 99 days median2016: 159 days median2017: 56 days median2019: 247 days median2020: 189 days median2021: 396 days median2022: 278 days median2023: 90 days median2024: 166 days median2025: 196 days median
2007high 396 (2021) · low 56 (2017)2026

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

Recalls per year · LHI

1in 2024

2007: 12008: 32009: 12010: 32011: 122013: 32016: 1, 1 Class I2017: 12018: 3, 3 Class I2019: 12022: 22023: 2, 2 Class I2024: 12026 (partial year): 1
2007high 12 (2011) · low 0 (2012)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · LHI

1,334in 2025

2007: 182008: 272009: 372010: 492011: 1552012: 5292013: 1542014: 1552015: 1282016: 2192017: 5362018: 1,4992019: 1,6342020: 1,1712021: 9332022: 1,8342023: 1,0472024: 1,2702025: 1,334
2007high 1,834 (2022) · low 18 (2007)2025

MAUDE reports naming product code LHI, 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
2007389118
20084154327
2009895137
20105139349
201139912155
201251270529
201341023154
20146630155
20153990128
201631591 (1)219
20175561536
20181—3 (3)1,499
2019424711,634
2020318901,171
202133960933
2022627821,834
20235902 (2)1,047
2024916611,270
2025619601,334
20262—1—

More from Baxa Corp., Sub. of Cook Group, Inc.

16 FDA decisions under this applicant name. See the company

  • K910257Baxa Pca InfusorBaxa Corp., Sub. of Cook Group, Inc. · 1991
  • K903159Valve Controller for Micromacro CompounderBaxa Corp., Sub. of Cook Group, Inc. · 1990
  • K904225KwikmixBaxa Corp., Sub. of Cook Group, Inc. · 1990
  • K873875Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 1987
  • K872743Baxa Tubing Sets (for Pharmacy Pump)Baxa Corp., Sub. of Cook Group, Inc. · 1987

Recent decisions in LHI

The LHI category page

  • K252987ADRx™ Admixture DeviceEpic Medical Pte., Ltd. · 2026
  • K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
  • K250345Medline Bag DecanterMedline Industries, LP · 2025
  • K251715FlowArt® Vial Access Device VentedAsset Medikal · 2025
  • K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S)…Microtek Medical, LLC · 2025

https://510kreport.com/device/K900585 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900585: Tubing Sets for Baxa Exacta-Med Pharmacy Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900585

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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