510(k) Report

FDA applicant

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

Mchenry, IL16 decisions1978–199137 recalls

FDA records 16 decisions for Baxa Corp., Sub. of Cook Group, Inc. (Mchenry, IL) from 1978 to 1991: 16 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and KPE (Container, I.V.). 37 recalls are linked to its devices, 1 Class I.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Baxa Corp., Sub. of Cook Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Baxa Corp., Sub. of Cook Group, Inc. since 2007.

Recalls per year

1in 2019

2009: 42010: 122011: 62013: 12016: 1, 1 Class I2018: 52019: 1
2007high 12 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Baxa Corp., Sub. of Cook Group, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Baxa Corp., Sub. of Cook Group, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LHISet, I.V. Fluid Transfer7decisions
  • KPEContainer, I.V.5decisions
  • FMFSyringe, Piston1decision
  • FRNPump, Infusion1decision
  • MEAPump, Infusion, Pca1decision
  • KYXDispenser, Liquid Medication1decision

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K872743Baxa Tubing Sets (for Pharmacy Pump)Baxa Corp., Sub. of Cook Group, Inc. · 19871cites it
  • K900585Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 19901cites it
  • K832347Twofer NeedleBaxa Corp., Sub. of Cook Group, Inc. · 19831cites it
  • K904225KwikmixBaxa Corp., Sub. of Cook Group, Inc. · 19901cites it

What has FDA decided for it lately?

  • 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
  • K900585Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 19901 Class I recall
  • 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
  • K844904Cytosafe NeedleBaxa Corp., Sub. of Cook Group, Inc. · 1985
  • K832347Twofer NeedleBaxa Corp., Sub. of Cook Group, Inc. · 1983

All 16 as Baxa Corp., Sub. of Cook Group, Inc. →

What has been recalled?

37 recalls linked to its devices; the latest:

  • K900585EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and…Sep 18, 2019Class II
  • K900585EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold…Sep 12, 2018Class II
  • K900585EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold…Sep 12, 2018Class II
  • K900585EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold…Sep 12, 2018Class II
  • K900585EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold…Sep 12, 2018Class II
  • K900585EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold…Sep 12, 2018Class II

Other applicant names beginning “Baxa”

FDA records each applicant name separately; these may or may not be the same firm.

Baxa Corp. 8Baxa Infusion Systems 1