510(k) Report

FDA applicant

The Kendal Co.

Boston, MA63 decisions1980–200020 recalls

FDA records 63 decisions for The Kendal Co. (Boston, MA) from 1980 to 2000: 63 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and KNX (Collector, Urine, (And Accessories) For…). Its devices cite 6 predicates, 1 of them its own earlier devices. 20 recalls are linked to its devices, 2 Class I.

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 The Kendal Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Kendal Co. since 2007.

Recalls per year

2in 2023

2013: 12016: 172023: 2, 2 Class I
2007high 17 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — The Kendal Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like The Kendal Co.’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?

  • KODCatheter, Urological7decisions
  • KNXCollector, Urine, (And Accessories) For Indwelling Catheter6decisions
  • DQYCatheter, Percutaneous3decisions
  • CAZAnesthesia Conduction Kit3decisions
  • FPASet, Administration, Intravascular2decisions
  • EZLCatheter, Retention Type, Balloon2decisions

Also: LJE (2), KGX (2), JOW (2), IMD (2), DYB (2), GBM (2).

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 1 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.

  • K942664Kendall Model 6325 SCD Sequel Compression SystemThe Kendal Co. · 19954cite it
  • K991758Monoject Insulin SyringeThe Kendal Co. · 19993cite it
  • K860484Curity & Kenguard Silicone Coated Foley CatheterThe Kendal Co. · 19862cite it
  • K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946CThe Kendal Co. · 19992cite it
  • K842899Curity Suprapubic Drainage SystemThe Kendal Co. · 19841cites it
  • K863581Modified Model 5320 T.E.D. Compression LimbThe Kendal Co. · 19861cites it

What has FDA decided for it lately?

  • K000087Marhukar Triple Lumen Catheter, Model 12 FRThe Kendal Co. · 2000
  • K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946CThe Kendal Co. · 19991 Class I recall
  • K991758Monoject Insulin SyringeThe Kendal Co. · 1999
  • K970969Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetThe Kendal Co. · 1997
  • K951488Kendall Curity Catheter Plug with Protective CapThe Kendal Co. · 1995
  • K942664Kendall Model 6325 SCD Sequel Compression SystemThe Kendal Co. · 1995
  • K942774Polyskin (R) M.R. Moist Responsive Transparent DressingThe Kendal Co. · 1994
  • K892434Kendall Curity Oxygen MaskThe Kendal Co. · 1989

All 63 as The Kendal Co. →

What has been recalled?

20 recalls 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
  • K860484Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG…Dec 4, 2023Class I
  • K100603Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes…Jan 22, 2016Class II
  • K100603Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are…Jan 22, 2016Class II
  • K100603Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are…Jan 22, 2016Class II
  • K100603Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes…Jan 22, 2016Class II