510(k) Report

FDA applicant

Kendall

Mansfield, MA22 decisions1999–2009108 recalls

FDA records 22 decisions for Kendall (Mansfield, MA) from 1999 to 2009: 22 510(k) clearances. Most are in product codes MSD (Catheter, Hemodialysis, Implanted) and FEG (Tube, Double Lumen For Intestinal…). Its devices cite 23 predicates, 5 of them its own earlier devices. 108 recalls are linked to its devices, 26 Class I.

FDA’s records also spell it “The Kendall Company”, “The Kendall Company, L.P.”.

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 Kendall’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

25in 2023

2008: 42015: 622018: 62019: 12022: 1, 1 Class I2023: 25, 25 Class I
2007high 62 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Kendall 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?

  • MSDCatheter, Hemodialysis, Implanted9decisions
  • FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation2decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions
  • FRODressing, Wound, Drug1decision
  • NGTSaline, Vascular Access Flush1decision
  • NFKKit, Repair, Catheter, Hemodialysis1decision

Also: KNT (1), NAD (1), FLL (1), NIE (1), MPB (1), JOW (1).

Whose devices does it build on?

Its devices cite 23 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 5 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.

  • K990530Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P. · 20005cite it
  • K043272Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical TipKendall · 20044cite it
  • K003313Filac Fas Temp Electronic ThermometerThe Kendall Company · 20014cite it
  • K020089Mahurkar Triple Lumen Catheter, 12 FRThe Kendall Company · 20024cite it
  • K030209Mahurkar Oplus Catheter, Model 13.5 FRThe Kendall Company · 20033cite it
  • K992079Kendall Model 7325 SCD Response Compression System, Model 7325The Kendall Company, L.P. · 19993cite it

What has FDA decided for it lately?

  • K092797Acute and Chronic Catheter Repair KitKendall · 20091 recall
  • K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire)Kendall · 200624 recalls
  • K061936Kendall Argyle Neonatal/Pediatric Picc, Model 43311The Kendall Company · 2006
  • K060972Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)Kendall · 200638 recalls
  • K053410Gientriport with Universal Single Lumen AdaptorKendall · 2006
  • K05158414.5 FR Chronic Hemodialysis Catheter with Insertion Stylets AccessoryKendall · 20054 recalls
  • K043272Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical TipKendall · 2004
  • K042461Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304Kendall · 20041 recall

All 12 as Kendall →All 8 as The Kendall Company →All 2 as The Kendall Company, L.P. →

What has been recalled?

108 recalls linked to its devices; the latest:

  • K020089MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight…Jun 28, 2023Class I
  • K020089MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved…Jun 28, 2023Class I
  • K020089MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved…Jun 28, 2023Class I
  • K020089MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF…Jun 28, 2023Class I
  • K020089MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight…Jun 28, 2023Class I
  • K020089MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight…Jun 28, 2023Class I

Other applicant names beginning “Kendall”

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

Kendall Healthcare Products Co. Div.Of Tyco Health 66Kendall Research Center 14Kendall Mcgaw Laboratories, Inc. 13The Kendall Company Div. of Tyco Healthcare Group 4Kendall-Ltp 1