510(k) Report

510(k) · Cleared

Cleared

Cure Catheter Closed System

K080881510(k) TraditionalCleared Jun 11, 200872-day reviewClass II21 CFR 876.5130

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

Cure Medical, LLC · KOD Catheter, Urological

Cleared on Jun 11, 2008 as substantially equivalent to K010420 (Rusch, Inc., 2001) after a 72-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.

Decided
Jun 11, 2008
Review
72 days
Class
Class II
Product code
KOD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K010420 (2001). 10 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2025: 2 descendants cleared2018: 1 descendant cleared2026: 2 descendants clearedK010420 · Rusch MMG/O'neil Catheter · Rusch, Inc. · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants K010420 · Rusch MMG/O'neil Catheter · Rusch, Inc. · 2001 · recalled0
  1. Root · 1 generation backK010420 Rusch MMG/O'neil CatheterRusch, Inc. · 2001 · Recalled
  2. This deviceK080881 Cure Catheter Closed SystemCure Medical, LLC · 2008
  3. Descendant · cites it directly · 4 of its ownK110653 Cure CatheterCure Medical, LLC · 2011 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK132500 Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure…Cure Medical, LLC · 2013
  5. Descendant · cites it directly · 2 of its ownK221593 Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusConvatec, Inc. · 2022
  6. Descendant · 2 generations on · 1 of its ownK250699 Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter…Convatec · 2025
  7. Descendant · cites it directly · 1 of its ownK230400 Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc. · 2023

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011: 12013: 12016: 12018: 12022: 12023: 12025: 22026: 2
2011high 2 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 10 · See all
  • K110653Cure CatheterCure Medical, LLC · 2011 · cites it directly4descendants
  • K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Cure Medical, LLC · 2013 · 2 generations on3descendants
  • K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusConvatec, Inc. · 2022 · cites it directly2descendants
  • K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist…Convatec · 2025 · 2 generations on1descendant
  • K230400Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc. · 2023 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010420Rusch MMG/O'neil CatheterRusch, Inc.20013
0 (this device)K080881Cure Catheter Closed SystemCure Medical, LLC2008—
+1K110653Cure CatheterCure Medical, LLC20111
+2K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter…Cure Medical, LLC2013—
+1K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusConvatec, Inc.2022—
+2K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure…Convatec2025—
+1K230400Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201310
201610
201810
202210
202310
202520
202620
FIG. 1 — Lineage of K080881, 2001–2026Source: 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), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K010420Rusch MMG/O'neil Catheter
Summary page 1
…Procode: KOD/FCM CFR Reference: 876.5130 Predicate Device: Rusch MMG/O'Neil Catheter (KO10420) Predicate 510(k) #: K010420 (Rusch) Device Description: The Cure CatheterTM Closed System is an intermittent urinary ca…
Rusch, Inc.20013

Also cleared against K010420: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K110653Cure CatheterCure Medical, LLC20114
K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusConvatec, Inc.20222
K230400Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc.20231
K151745FULL CARE Disposable PVC Nelaton CatheterShaoxing Fuqing Health Products Co., Ltd.20160

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K110653 (Cure Medical, LLC, 2011) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K010420.

How does its category compare?

All KOD devices

KOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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—

What is it indicated for?

The Cure Catheter TM Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

Indications for use as stated in the FDA summary.

Also cleared against K010420

2 other devices cite the same predicate.

  • K033477Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitRochester Medical Corp. · 20043 recalls
  • K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc. · 2002

More from Cure Medical, LLC

4 FDA decisions under this applicant name. See the company

  • K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter…Cure Medical, LLC · 2013
  • K110653Cure CatheterCure Medical, LLC · 20111 recall
  • K072539Cure CatheterCure Medical, LLC · 20071 recall

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/K080881 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080881: Cure Catheter Closed System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080881

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026