510(k) Report

FDA applicant

The Kendall Company Div. of Tyco Healthcare Group

Mchenry, IL4 decisions1983–20031 recall

FDA records 4 decisions for The Kendall Company Div. of Tyco Healthcare Group (Mchenry, IL) from 1983 to 2003: 4 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and GJG (Pipette, Quantitative, Hematology). 1 recall is 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, clinical chemistry panel, where it files most

How often FDA has decided The Kendall Company Div. of Tyco Healthcare Group’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Kendall Company Div. of Tyco Healthcare Group since 2007.

Recalls per year

1in 2023

2023: 1, 1 Class I
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — The Kendall Company Div. of Tyco Healthcare Group by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • GJGPipette, Quantitative, Hematology1decision
  • BYXTubing, Pressure And Accessories1decision
  • EZLCatheter, Retention Type, Balloon1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K024010Dover Silver Hydrogel Coated Silicone Foley CatheterThe Kendall Company Div. of Tyco Healthcare Group · 20031cites it

What has FDA decided for it lately?

  • K024010Dover Silver Hydrogel Coated Silicone Foley CatheterThe Kendall Company Div. of Tyco Healthcare Group · 20031 Class I recall
  • K831081Ezee Filter/SeparatorThe Kendall Company Div. of Tyco Healthcare Group · 1983
  • K831082Connecting TubingThe Kendall Company Div. of Tyco Healthcare Group · 1983
  • K831079LiquipetteThe Kendall Company Div. of Tyco Healthcare Group · 1983

All 4 as The Kendall Company Div. of Tyco Healthcare Group →

What has been recalled?

1 recall linked to its devices; the latest:

  • K780062Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG…Dec 4, 2023Class I

Other applicant names beginning “The”

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

Kendall Healthcare Products Co. Div.Of Tyco Health 66Kendall 22Kendall Research Center 14Kendall Mcgaw Laboratories, Inc. 13Kendall-Ltp 1