510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Nelaton-, Female - or Tiemann Catheter

K896729510(k) TraditionalCleared Nov 5, 1990340-day reviewClass II21 CFR 876.5130Recalls 14

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

Unoplast A/S · KOD Catheter, Urological

Cleared on Nov 5, 1990 after a 340-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled 14 times.

Decided
Nov 5, 1990
Review
340 days
Class
Class II
Product code
KOD
Recalls
14
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2007: 1 descendant cleared2017: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2016: 2 descendants cleared2015: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK896729 Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 1990
  2. Descendant · cites it directly · 9 of its ownK033023 Intermittent Urethral CathetersRusch Intl. · 2003
  3. Descendant · 2 generations on · 5 of its ownK072539 Cure CatheterCure Medical, LLC · 2007 · Recalled
  4. Descendant · 3 generations on · 4 of its ownK110653 Cure CatheterCure Medical, LLC · 2011 · Recalled
  5. Descendant · 3 generations on · 3 of its ownK132500 Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure…Cure Medical, LLC · 2013
  6. Descendant · 2 generations on · 2 of its ownK111405 Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip /…Hangzhou Bever Medical Devices Co., Ltd. · 2012

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12011: 12012: 12013: 12014: 12015: 12016: 22017: 12018: 12026: 1
2003high 2 (2016) · low 0 (2004)2026

Most influential descendants

Showing 5 of 12 · See all
  • K033023Intermittent Urethral CathetersRusch Intl. · 2003 · cites it directly9descendants
  • K072539Cure CatheterCure Medical, LLC · 2007 · 2 generations on5descendants
  • K110653Cure CatheterCure Medical, LLC · 2011 · 3 generations on4descendants
  • K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Cure Medical, LLC · 2013 · 3 generations on3descendants
  • K111405Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…Hangzhou Bever Medical Devices Co., Ltd. · 2012 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896729Nelaton-, Female - or Tiemann CatheterUnoplast A/S1990—
+1K033023Intermittent Urethral CathetersRusch Intl.2003—
+2K072539Cure CatheterCure Medical, LLC20071
+3K110653Cure CatheterCure Medical, LLC20111
+3K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter…Cure Medical, LLC2013—
+2K111405Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…Hangzhou Bever Medical Devices Co., Ltd.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
201110
201210
201310
201410
201510
201620
201710
201810
202610
FIG. 1 — Lineage of K896729, 1990–2026Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K033023Intermittent Urethral CathetersRusch Intl.20039
K140953Gentlecath Male Coude Olive Tip Intermittent Urinary CatheterConvatec, Ltd.20141

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 9, 2019Class IIZ-1037-2019Package design/selectionAn internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Jun 30, 2011Not classifiedZ-2934-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2942-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2944-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2941-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2938-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2940-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2935-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2936-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2943-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2939-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2932-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2937-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
Jun 30, 2011Not classifiedZ-2933-2011OtherPin holes were detected in the packaging therefore sterility of the device can not be guaranteed.

The 5 latest of 14 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033023 (Rusch Intl., 2003) has gone furthest, with 9 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 Unoplast A/S

7 FDA decisions under this applicant name. See the company

  • K896734Feeding TubeUnoplast A/S · 19901 recall
  • K896732Unometer 500Unoplast A/S · 1990
  • K896731Oxygen CathetersUnoplast A/S · 1990
  • K896730Suction Catheter Straight/CoudeUnoplast A/S · 1990
  • K896733VacconUnoplast A/S · 1990

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/K896729 · printed Nov 4, 2026

Cite this page

510(k) Report. “K896729: Nelaton-, Female - or Tiemann Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896729

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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