510(k) Report

FDA applicant

Covidien Lp, Formerly Registered AS Kendall

Mansfield, MA3 decisions2009–20133 recalls

FDA records 3 decisions for Covidien Lp, Formerly Registered AS Kendall (Mansfield, MA) from 2009 to 2013: 3 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and MSD (Catheter, Hemodialysis, Implanted). Its devices cite 5 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Covidien Lp, Formerly Registered AS Kendall’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 12012: 12013: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

3in 2025

2025: 3
2009high 3 (2025) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Covidien Lp, Formerly Registered AS Kendall by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • MSDCatheter, Hemodialysis, Implanted1decision
  • FOSCatheter, Umbilical Artery1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K112511Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 20123cite it
  • K092205Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 20092cite it
  • K130725Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR.Covidien Lp, Formerly Registered AS Kendall · 20131cites it

What has FDA decided for it lately?

  • K130725Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 FR.Covidien Lp, Formerly Registered AS Kendall · 20133 recalls
  • K112511Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012
  • K092205Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009

All 3 as Covidien Lp, Formerly Registered AS Kendall →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K130725Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumenMay 2, 2025Class II
  • K130725Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumenMay 2, 2025Class II
  • K130725Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumenMay 2, 2025Class II

Other applicant names beginning “Covidien”

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

Covidien 227Covidien, Formerly US Surgical A Divison of Tyco H 13Covidien Lp, Formerly Registered AS United States 8Covidien, Formerly Valleylab, A Division of Tyco H 6Covidien, Formerly Nellcor Puritan Bennett, Inc. 5Covidien Lp, Formerly Registered AS Tyco Healthcar 4Covidien, LLC ( Formerly Beacon Endoscopic Corp.) 2Covidien (Part of Medtronic) 2Covidien, LLC, Formerly Registered AS Tyco Healthca 2Covidien Lp, Formerly Know AS Valleylab, A Divison 2Covidien (Dba Medtronic) 1Covidien UK Manufacturing, Ltd. 1