510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Kendall Curity 100% Silicone Foley Catheter W/Temperature Sensor

K933400510(k) TraditionalCleared Nov 15, 1993126-day reviewClass II21 CFR 876.5130Recalls 17

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kendall Healthcare Products Co. Div.Of Tyco Health · KOD Catheter, Urological

Cleared on Nov 15, 1993 after a 126-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 17 times.

Decided
Nov 15, 1993
Review
126 days
Class
Class II
Product code
KOD
Recalls
17
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK933400 Kendall Curity 100% Silicone Foley Catheter W/Temperature SensorKendall Healthcare Products Co. Div.Of Tyco Health · 1993
  2. Descendant · cites it directly · 0 of its ownK042709 Dover Silver Temperature Sensing Foley CatheterTyco Healthcare · 2005
  3. Descendant · cites it directly · 0 of its ownK990509 Oligon Foley Catheter (16 FR) #33816/Oligon Foley Catheter (18 FR)…Implemed, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K042709Dover Silver Temperature Sensing Foley CatheterTyco Healthcare · 2005 · cites it directly0descendants
  • K990509Oligon Foley Catheter (16 FR) #33816/Oligon Foley Catheter (18 FR) #33818Implemed, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933400Kendall Curity 100% Silicone Foley Catheter W/Temperature SensorKendall Healthcare Products Co. Div.Of Tyco Health1993—
+1K042709Dover Silver Temperature Sensing Foley CatheterTyco Healthcare2005—
+1K990509Oligon Foley Catheter (16 FR) #33816/Oligon Foley Catheter (18 FR) #33818Implemed, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200510
FIG. 1 — Lineage of K933400, 1993–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KOD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KOD device

  1. #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042709Dover Silver Temperature Sensing Foley CatheterTyco Healthcare20050
K990509Oligon Foley Catheter (16 FR) #33816/Oligon Foley Catheter (18 FR) #33818Implemed, Inc.19990

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 30, 2020Class IIZ-1989-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1993-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1986-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1991-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1994-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1985-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1990-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1992-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1987-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1984-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Apr 30, 2020Class IIZ-1988-2020Nonconforming Material/ComponentTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Jul 11, 2018Class IIZ-3207-2018Nonconforming Material/ComponentThe temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Jul 11, 2018Class IIZ-3205-2018Nonconforming Material/ComponentThe temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Jul 11, 2018Class IIZ-3206-2018Nonconforming Material/ComponentThe temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Jul 11, 2018Class IIZ-3204-2018Nonconforming Material/ComponentThe temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Jul 11, 2018Class IIZ-3208-2018Nonconforming Material/ComponentThe temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Jul 11, 2018Class IIZ-3203-2018Nonconforming Material/ComponentThe temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K042709 (Tyco Healthcare, 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KOD devices

KOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOD

2in 2022

2008: 22009: 12010: 12011: 22014: 12016: 22017: 12018: 62019: 12021: 12022: 22026 (partial year): 1
2007high 6 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KOD

251in 2018

2018: 251 days median
2007high 251 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KOD

1in 2023

2009: 152010: 12011: 472012: 22016: 12019: 12022: 32023: 1, 1 Class I2026 (partial year): 1
2007high 47 (2011) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KOD

1,389in 2025

2007: 1802008: 1022009: 1832010: 2282011: 2092012: 1652013: 3932014: 2262015: 4182016: 2842017: 1,8732018: 1,1792019: 1,1672020: 1,3702021: 1,3882022: 1,2802023: 1,1602024: 1,2592025: 1,389
2007high 1,873 (2017) · low 102 (2008)2025

MAUDE reports naming product code KOD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0180
20082—0102
20091—15183
20101—1228
20112—47209
20120—2165
20130—0393
20141—0226
20150—0418
20162—1284
20171—01,873
2018625101,179
20191—11,167
20200—01,370
20211—01,388
20222—31,280
20230—1 (1)1,160
20240—01,259
20250—01,389
20261—1—

More from Kendall Healthcare Products Co. Div.Of…

66 FDA decisions under this applicant name. See the company

  • K973763Kendall Curity Iodoform Packing StripKendall Healthcare Products Co. Div.Of Tyco Health · 1997
  • K973511Kendall Curity Petrolatum GauzeKendall Healthcare Products Co. Div.Of Tyco Health · 1997
  • K973507Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)Kendall Healthcare Products Co. Div.Of Tyco Health · 1997
  • K973619Kendall Curity Non-Adhering DressingKendall Healthcare Products Co. Div.Of Tyco Health · 1997
  • K973509Kendall Curasorb ZN + MG Alginate Wound DressingKendall Healthcare Products Co. Div.Of Tyco Health · 1997

Recent decisions in KOD

The KOD category page

  • K251864Rubber Utility CatheterC.R. Bard, Inc. · 2026
  • K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd. · 2022
  • K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc. · 2022
  • K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd. · 2021
  • K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc. · 2019

https://510kreport.com/device/K933400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933400: Kendall Curity 100% Silicone Foley Catheter W/Temperature Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933400

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026