510(k) Report

510(k) · Decided

Decided

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C

K250891510(k) SpecialDecided Jun 6, 202573-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

Convatec Limited · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Cleared on Jun 6, 2025 as substantially equivalent to K230400 (Convatec, Inc., 2023) after a 73-day review. Its family tree reaches back 3 generations to 2001.

Decided
Jun 6, 2025
Review
73 days
Class
Class II
Product code
FCM
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K010420 (2001). No later device cites it as a predicate yet.

K010420 · Rusch MMG/O'neil Catheter · Rusch, Inc. · 2001 · recalledK080881 · Cure Catheter Closed System · Cure Medical, LLC · 2008K230400 · Cure Catheter Closed System; Cure Dextra Closed System · Convatec, Inc. · 2023200020052010201520202025
K230400 · Cure Catheter Closed System; Cure Dextra Closed System · Convatec, Inc. · 2023K080881 · Cure Catheter Closed System · Cure Medical, LLC · 2008K010420 · Rusch MMG/O'neil Catheter · Rusch, Inc. · 2001 · recalled0
  1. Root · 3 generations backK010420 Rusch MMG/O'neil CatheterRusch, Inc. · 2001 · Recalled
  2. 2 generations backK080881 Cure Catheter Closed SystemCure Medical, LLC · 2008
  3. 1 generation backK230400 Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc. · 2023
  4. This deviceK250891 Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2)…Convatec Limited · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K010420Rusch MMG/O'neil CatheterRusch, Inc.20013
−2K080881Cure Catheter Closed SystemCure Medical, LLC2008—
−1K230400Cure Catheter Closed System; Cure Dextra Closed SystemConvatec, Inc.2023—
0 (this device)K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure…Convatec Limited2025—
FIG. 1 — Lineage of K250891, 2001–2025Source: 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 FCM? 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 FCM device

  1. #1 K254076 BD Touchless™ Plus Unisex Pre-Lubricated…score 11.4 · 1 generation · no Class I recall
  2. #2 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
*K230400Cure Catheter Closed System; Cure Dextra Closed System
Summary page 5
…al catheter and accessories Regulation Number 21 CFR 876.5130 Product Code FCM Classification II Primary Predicate Cure Catheter Closed System (K230400) Device Purpose of Device modification Submission Device Description The Cure Catheter Insertion Kits (K1, K2, K2-9…
Convatec, Inc.2023—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
  • 1 of the 3 ancestors has a recall of any class.

How does its category compare?

All FCM devices

FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · FCM

1in 2025

2007: 22008: 12023: 12025: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FCM

Too few FCM 510(k)s in any year since 2007 to give a median.

Recalls per year · FCM

1in 2023

2011: 312022: 62023: 1, 1 Class I
2007high 31 (2011) · low 0 (2007)2026

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

Adverse event reports per year · FCM

35in 2025

2007: 12008: 32009: 62010: 32011: 42012: 32013: 42014: 62015: 52016: 142017: 332018: 612019: 792020: 862021: 852022: 592023: 482024: 542025: 35
2007high 86 (2020) · low 1 (2007)2025

MAUDE reports naming product code FCM, 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
20072—01
20081—03
20090—06
20100—03
20110—314
20120—03
20130—04
20140—06
20150—05
20160—014
20170—033
20180—061
20190—079
20200—086
20210—085
20220—659
20231—1 (1)48
20240—054
20251—035
20261—0—

What is it indicated for?

The Cure Catheter insertion Kit is an intermittent urinary catheter kit indicated for the purpose of bladder drainage for males and females. The urinary catheter kit comes in a variety of configurations and sizes packaged sterile for single-use.

Indications for use as stated in the FDA summary.

More from Convatec Limited

10 FDA decisions under this applicant name. See the company

  • K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenConvatec Limited · 2026
  • K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited · 2022
  • K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited · 2019
  • K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited · 2018
  • K181206GentleCath Glide Intermittent Urinary CatheterConvatec Limited · 2018

Recent decisions in FCM

The FCM category page

  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026
  • K223821Self-Cath Closed SystemColoplast · 2023
  • K082831Amself Closed Catheterization SystemAmsino International, Inc. · 2008
  • K070939Self-Cath CS Closed Urinary Catheterization SystemColoplast Manufacturing Us, LLC · 2007
  • K070048Guardian Catheter-Infant Urinary Collection KitMarian Medical, Inc. · 2007

https://510kreport.com/device/K250891 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250891: Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250891

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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